STAY AHEAD OF
COMPLIANCE
AUDIT
TRAINING
BUDGET
CAPA
VENDOR SELECTION
VENDOR OVERSIGHT
SPEND RECONCILIATION
GOVERNANCE
CHANGE ORDERS
Unify Quality Compliance, Quality Assurance, Procurement, Oversight & Spend
One AI-powered platform connecting Quality Compliance (SOPs, Documents, Learning), Quality Assurance (Audits, CAPA, Inspections), Procurement (RFP, Vendor Selection, Contracts), Oversight (Vendor Scorecards, Risk Management), and Spend (Budget, Payments, Reconciliation) — with clinical-grade AI agents and Human-in-the-Loop experts.
QPOS EW Bridge: APAC ↔ North America Excellence
Our exclusive East-West Bridge service enables seamless full-service support for NA sponsors operating in APAC and APAC sponsors expanding to North America — with native expertise, timezone coverage, and regulatory fluency across both regions.
The Challenges
Life sciences organizations struggle with fragmented systems, manual processes, and disconnected data across quality, procurement, and financial operations.
Quality & Compliance Challenges
- SOPs disconnected from training records and CAPA investigations
- Audit findings lack traceability to root causes and process improvements
- Inspection readiness requires weeks of manual evidence compilation
- CAPA effectiveness checks are subjective and inconsistent
- Change control impacts on training and documentation are missed
- Quality metrics don't connect to operational performance
Procurement & Vendor Challenges
- Vendor selection relies on spreadsheets and email chains
- RFP processes take months with limited vendor comparison
- Contract terms are buried in PDFs with no change tracking
- Vendor risk scoring is manual and inconsistently applied
- Audit findings and CAPAs don't update vendor scorecards
- Procurement governance is disconnected from quality oversight
Financial & Spend Challenges
- Budget vs. actual reconciliations take days of manual work
- Invoice matching requires three-way verification across systems
- Change orders create budget overruns with no early warnings
- Accruals and reversals lack supporting documentation
- Month-end close is delayed by vendor invoice discrepancies
- Financial impact of quality issues is invisible until too late
The Root Problem: Disconnected Systems & Broken Traceability
When quality, procurement, and finance operate in silos with separate systems and manual handoffs, organizations lose the ability to trace decisions from SOP to spend. This fragmentation creates compliance risk, operational inefficiency, and financial exposure — all while consuming hundreds of hours in reconciliation and audit preparation.
The Value We Provide
QPOS delivers Q²POS Traceability™ — a unified fabric that connects every action from SOP to reconciliation, powered by AI agents and validated by human experts.
Operational Excellence
- ✓ End-to-end traceability from SOPs to training to CAPA to spend reconciliation
- ✓ AI + HITL automation that combines machine speed with human expertise
- ✓ Single source of truth eliminating duplicate data entry and reconciliation
- ✓ Real-time visibility into compliance status, vendor risk, and financial exposure
Business Impact
- ✓ Inspection confidence with always-ready evidence and complete audit trails
- ✓ Vendor performance improvement through risk-based oversight and scorecards
- ✓ Cost avoidance by catching variances, change orders, and overruns early
- ✓ Productivity gains freeing quality, procurement, and finance teams for strategic work
Transformation in Action
See how a mid-size biopharma transformed their quality, procurement, and financial operations with QPOS in 90 days.
Current State: Fragmented & Manual
Quality Operations
- ✗ 4-6 weeks to prepare for FDA inspections, manually compiling evidence from 7 different systems
- ✗ CAPA investigations averaging 45 days with inconsistent root cause analysis
- ✗ Training records disconnected from SOPs, requiring manual retraining identification
Vendor Management
- ✗ 6-9 months to select and qualify new CRO vendors using spreadsheets
- ✗ Vendor audit findings tracked in SharePoint, not linked to contracts or risk scores
- ✗ No visibility into vendor performance across studies until quarterly reviews
Financial Controls
- ✗ 15-day month-end close with 60% of time spent on invoice reconciliations
- ✗ Budget variances discovered 30-45 days after change orders were approved
- ✗ No connection between quality findings (deviations, CAPAs) and financial impact
Future State: Unified & Automated
Quality Operations
- ✓ 2-3 days for inspection readiness with automated evidence linking across all quality events
- ✓ 18 days average CAPA closure with AI-assisted root cause analysis and HITL validation
- ✓ Training automatically triggered by SOP changes with full audit trail from document to competency
Vendor Management
- ✓ 6-8 weeks to select and qualify vendors with AI-powered RFP analysis and proposal scoring
- ✓ Audit findings auto-update vendor risk scores and trigger contract review workflows
- ✓ Real-time vendor performance dashboards with predictive risk alerts across all studies
Financial Controls
- ✓ 6-day close with AI-assisted three-way matching and automated variance analysis
- ✓ Budget impact alerts within 24 hours of change control approval with forecasted overruns
- ✓ Quality events (deviations, CAPAs) automatically linked to cost impact and vendor invoices
Potential Transformation Results
Services
Expert professional services that work with any quality, procurement, or financial system — delivered by specialists who understand GxP compliance and operational excellence. We also provide GMP and GCP auditors to conduct all types of audit services.
Consulting Services
- Inspection Readiness Assessment
- Vendor Risk Assessment & Qualification Strategy
- Budget Structure & Reconciliation Framework Design
- Process Optimization & Gap Analysis
- Regulatory Compliance Advisory
- Digital Transformation Roadmap
Managed Services
- Human-in-the-Loop (HITL) Validation Services
- Ongoing CAPA & Audit Support
- Vendor Oversight & Performance Monitoring
- Financial Reconciliation Operations
- Quality System Maintenance
- Continuous Compliance Monitoring
Implementation Services
- QMS/LMS Implementation & Migration
- Procurement System Configuration
- Financial Integration & Setup
- User Training & Change Management
- Validation Services (CSV for 21 CFR Part 11)
- Go-Live Support & Hypercare
Platform
The Q²POS Platform unifies Quality Compliance, Quality Assurance, Procurement, Oversight and Spend into a single integrated system — where every action is traceable from SOP to vendor selection to financial reconciliation.
Quality Compliance
- SOPs & controlled documents
- Regulatory impact assessment
- Learning Management & competency
- Change & risk management
Quality Assurance
- Audit management & execution
- CAPA investigations & tracking
- Incidents & events management
- Inspection readiness
Procurement
- RFI / RFP management
- Supplier due diligence & selection
- Vendor qualification workflows
- Contract lifecycle management
Oversight
- Vendor scorecards & performance tracking
- Vendor management & lifecycle
- Change control integration
- Risk-based quality monitoring
Spend Management
- Budget planning & allocation
- Monthly variance reporting
- Payments & approval workflows
- Milestones & invoice reconciliation
Solutions
Pre-packaged solutions for Quality, Procurement and Finance teams, delivered on top of the QPOS platform and its AI agents.
Quality & Compliance
Drive inspection readiness and CAPA excellence with Finding Classification, RCA Advisor, Impact Analysis and Personalized Learning agents.
Procurement & Vendor Management
Streamline vendor discovery, RFPs and contracts, while keeping governance and change control aligned with your QMS.
Finance - FP&A
Connect contracts, milestones and invoices with Reconciliation and Validation agents to keep spend and reconciliations under control.
Cross-functional Control Tower
A single view across compliance, audits, procurement, vendor selection, governance, change control, spend and reconciliations.
Pricing
Flexible pricing tailored to your organization type — from emerging biopharma to global pharmaceutical enterprises and service providers.
Resources
Playbooks, templates and stories that show how organizations modernize clinical quality, procurement and reconciliations with QPOS.
Featured
- Q²POS Traceability – From SOP to Spend
- Building risk-based vendor oversight in 90 days
- Closing the loop on CAPA with AI & HITL
Templates
- Audit & inspection checklists
- RFP templates for CRO & vendor selection
- Budget & reconciliation workbooks
Why AuraGXP
Built by GxP experts who have lived the pain of fragmented systems — Q²POS is the first platform designed specifically to unify quality, procurement, and finance for life sciences.
QMS & Document Control
Centralized document control system that ensures version management, approval workflows, and full audit trails for all quality documentation.
Key Features
- Automated version control with change history tracking
- Multi-level approval workflows with electronic signatures
- Document categorization and advanced search capabilities
- Automated document expiry notifications and review reminders
- Role-based access control for sensitive documents
- Integration with training management for SOP updates
- PDF generation with watermarking and tamper detection
- Document templates and standardized formatting
Use Cases
- Standard Operating Procedures (SOPs)
- Work Instructions and Forms
- Quality Manuals and Policies
- Validation Protocols and Reports
- Technical Specifications
- Batch Records and Manufacturing Instructions
- Supplier Quality Agreements
- Regulatory Submissions
Learning Management System
Comprehensive training management platform that links SOPs, competencies, and CAPA actions to ensure qualified personnel and inspection readiness.
Training Management
- Automated curriculum assignment based on roles and responsibilities
- SOP-linked training with automatic assignment on document updates
- Multi-format content support (videos, documents, assessments, virtual labs)
- Competency assessments with pass/fail criteria
- Training effectiveness evaluation and analytics
- Certification tracking and renewal reminders
- Training record management with electronic signatures
- Mobile learning for shop floor accessibility
AI-Powered Agents
- Personalized Learning Agent: Adapts training content to individual learning styles and pace
- Knowledge Gap Analyzer: Identifies training deficiencies from CAPA and audit findings
- Curriculum Builder: Automatically creates role-based training paths
- Competency Predictor: Forecasts retraining needs based on performance trends
- Training Content Generator: Creates assessments and quizzes from SOPs
Audit & CAPA Management
Closed-loop quality management system that connects audits, deviations, CAPAs, and root cause analysis with full traceability to SOPs and training.
Audit Management
- Risk-based audit planning and scheduling
- Customizable audit checklists and templates
- Mobile audit execution with offline capability
- Finding classification and severity assignment
- Photo and evidence attachment management
- Real-time dashboard for audit status tracking
- Trend analysis across multiple audits
- Regulatory authority inspection support
CAPA Excellence
- Automated CAPA initiation from audit findings and deviations
- Guided root cause analysis (RCA) with multiple methodologies
- Impact analysis across products and processes
- Effectiveness verification with metrics tracking
- Automatic link to training for personnel-related CAPAs
- SOP update triggers for process-related CAPAs
- CAPA closure workflow with management approval
- Repeat finding prevention system
AI Agents for Quality Excellence
- Finding Classification Agent: Automatically categorizes audit observations by severity and regulatory requirement
- Root Cause Advisor: Suggests potential root causes using historical data and machine learning
- Impact Analysis Agent: Identifies all affected products, processes, and documentation
- CAPA Effectiveness Predictor: Assesses likelihood of corrective action success
- Repeat Finding Detector: Identifies patterns across audits to prevent recurring issues
Vendor Management & Oversight
End-to-end vendor lifecycle management from discovery and qualification to ongoing oversight and risk scoring with full governance integration.
Vendor Lifecycle
- AI-powered vendor discovery and market intelligence
- Automated due diligence with risk assessment
- Vendor qualification workflows with approval routing
- Contract management with milestone tracking
- Performance scorecards with KPI monitoring
- Audit scheduling and finding management
- Quality metrics and trending analysis
- Re-qualification and periodic review automation
Risk & Compliance
- Real-time vendor risk scoring across multiple dimensions
- Regulatory compliance monitoring (FDA, EMA, etc.)
- Quality agreement management and version control
- Change control notifications and impact assessment
- Deviation and CAPA tracking for suppliers
- Supply chain risk mapping and mitigation
- Vendor segmentation for risk-based oversight
- Continuous monitoring with alert escalation
AI Agents for Vendor Excellence
- Vendor Discovery Agent: Identifies qualified suppliers based on capabilities, certifications, and performance data
- Risk Scoring Engine: Continuously evaluates vendor risk across quality, financial, and operational dimensions
- Performance Predictor: Forecasts vendor performance trends and identifies at-risk relationships
- Audit Planner: Creates risk-based audit schedules optimizing resource allocation
- Contract Analyzer: Extracts key terms, identifies risks, and ensures governance alignment
Budget Planning & Reconciliation
Unified financial management connecting budgets, contracts, milestones, and invoices with automated reconciliation and variance analysis.
Budget Management
- Multi-level budget planning (study, vendor, category)
- Contract-linked budget allocation and tracking
- Milestone-based payment scheduling
- Real-time spend visibility across portfolio
- Budget vs. actual variance tracking
- Forecasting and trend analysis
- Budget reallocation workflows with approval
- Currency conversion and multi-entity support
Reconciliation & Controls
- Automated invoice-to-contract-to-PO matching
- Three-way reconciliation with exception management
- Change order tracking and impact analysis
- Accrual automation with milestone triggers
- Payment approval workflows with delegation
- Audit trail for all financial transactions
- Month-end close acceleration
- Integration with ERP systems (SAP, Oracle, NetSuite)
AI Agents for Financial Intelligence
- Reconciliation Agent: Automatically matches invoices to contracts and identifies discrepancies
- Variance Analysis Agent: Explains budget variances and flags anomalies
- Forecasting Agent: Predicts future spend based on historical trends and pipeline
- Audit Readiness Agent: Ensures all transactions have proper documentation and approvals
- Cash Flow Optimizer: Recommends optimal payment timing based on terms and cash position
Integrations & APIs
Enterprise-grade integration capabilities connecting QPOS with your existing technology ecosystem for seamless data flow and unified workflows.
API Capabilities
- RESTful APIs with comprehensive documentation
- GraphQL support for flexible data queries
- Webhook-based real-time event notifications
- Bulk data import/export with ETL support
- OAuth 2.0 and API key authentication
- Rate limiting and quota management
- Sandbox environments for testing
- API versioning for backward compatibility
- SDK libraries (Python, JavaScript, Java, .NET)
- Postman collections and OpenAPI specifications
Integration Support
- Custom integration development services
- ERP system connectivity (SAP, Oracle, Microsoft Dynamics, NetSuite)
- CTMS/eTMF platform integration
- Document management system connectivity
- HR and Learning management integration
- Business intelligence tool connections
- Communication platform integration
- Legacy system modernization support
Integration Patterns
- Real-time Sync: Bidirectional data synchronization for master data and transactional records
- Event-driven: Trigger workflows in external systems based on QPOS events (e.g., CAPA closure, document approval)
- Batch Processing: Scheduled data transfers for reporting and analytics
- Embedded UI: QPOS widgets embedded in external applications (e.g., vendor scorecards in procurement system)
- Single Sign-On: SAML 2.0 and OpenID Connect for unified authentication
Security & Compliance
Enterprise-grade security architecture with comprehensive compliance certifications ensuring your data is protected and regulatory requirements are met.
Data Security
- AES-256 encryption for data at rest
- TLS 1.3 for data in transit
- Multi-tenant architecture with data isolation
- Regular penetration testing and vulnerability assessments
- Intrusion detection and prevention systems
- DDoS protection and WAF (Web Application Firewall)
- Secure development lifecycle (SSDLC)
- Bug bounty program for responsible disclosure
Access & Identity
- Multi-factor authentication (MFA) with multiple methods
- Single Sign-On (SSO) with SAML 2.0 and OpenID Connect
- Role-based access control (RBAC) with granular permissions
- Attribute-based access control (ABAC) for complex scenarios
- Session management and timeout policies
- IP whitelisting and geofencing
- User activity monitoring and anomaly detection
- Privileged access management for administrators
Compliance & Certifications
- 21 CFR Part 11: Electronic records and signatures for FDA-regulated industries
- EU Annex 11: Computerized systems validation for pharmaceutical manufacturing
- SOC 2 Type II: Annual audit for security, availability, and confidentiality
- ISO 27001: Information security management system certification
- HIPAA: Health Insurance Portability and Accountability Act compliance
- GDPR: General Data Protection Regulation for EU data subjects
- GxP: Good practice quality guidelines (GMP, GLP, GCP)
- TISAX: Trusted Information Security Assessment Exchange (automotive)
Audit & Monitoring
- Comprehensive audit trails for all system actions
- Tamper-evident logging with cryptographic signatures
- Real-time security monitoring and alerting
- SIEM integration for centralized log management
- Compliance reporting and evidence collection
- Data retention policies with automated purging
Business Continuity
- Multi-region deployment with automatic failover
- Daily backups with point-in-time recovery
- Disaster recovery plan with RTO < 4 hours
- 99.9% uptime SLA with financial penalties
- Incident response team available 24/7/365
- Annual business continuity testing and validation
Inspection Readiness Solution
Comprehensive solution ensuring continuous regulatory compliance and audit preparedness through proactive quality management and intelligent monitoring.
The Challenge
FDA, EMA, and other regulatory inspections require organizations to demonstrate complete control over quality systems, document management, training records, and CAPA processes. Traditional reactive approaches leave gaps that result in observations, warning letters, and consent decrees.
The QPOS Solution
Our Inspection Readiness solution provides continuous monitoring, AI-powered gap detection, and automated evidence collection to ensure you're always audit-ready.
Key Capabilities
- Continuous Compliance Monitoring: AI agents scan quality systems 24/7 to identify potential compliance gaps before they become findings
- Intelligent Checklist Generator: Creates inspection-specific checklists based on latest regulatory guidance and your quality systems
- Training Record Verification: Ensures all personnel have current, complete training for their responsibilities
- Document Control Audit: Validates version control, approval workflows, and change management for all controlled documents
- CAPA Effectiveness Review: Analyzes CAPA completion rates, effectiveness, and trend towards zero repeat findings
- Mock Inspection Scenarios: Simulates regulatory inspections with AI playing the role of inspector
- Evidence Package Generator: Automatically compiles documentation for common inspection requests
- War Room Dashboard: Real-time coordination tool during actual inspections
Vendor Selection & Oversight Solution
Intelligent vendor management from discovery to ongoing oversight, ensuring quality, compliance, and performance across your supply chain.
Vendor Selection Process
- AI-Powered Discovery: Identifies qualified vendors based on capabilities, certifications, and industry reputation
- Automated RFP Management: Generate RFPs from templates, distribute to vendors, and analyze responses with AI
- Due Diligence Automation: Collects and validates regulatory status, financial health, and quality certifications
- Comparative Analysis: Side-by-side vendor comparison across price, quality, delivery, and risk factors
- Qualification Workflows: Structured approval process with stakeholder input and governance alignment
- Contract Negotiation: Template-based contracts with automated term extraction and risk flagging
Ongoing Oversight
- Performance Scorecards: Multi-dimensional vendor ratings updated in real-time with KPI tracking
- Risk Scoring Engine: Continuous monitoring across quality, financial, operational, and regulatory dimensions
- Quality Metrics Tracking: On-time delivery, defect rates, deviations, and CAPA responses
- Audit Management: Risk-based audit scheduling with mobile execution and finding tracking
- Change Control Monitoring: Alerts for vendor changes impacting your operations
- Performance Reviews: Quarterly business reviews with automated data collection and trend analysis
AI Agents for Vendor Intelligence
- Market Intelligence Agent: Monitors vendor landscape for new entrants, M&A activity, and capability changes
- RFP Analysis Agent: Evaluates vendor proposals against requirements with scoring and recommendation
- Risk Prediction Agent: Forecasts vendor performance issues before they impact operations
- Contract Compliance Agent: Ensures vendors meet contractual obligations and SLAs
- Sourcing Optimization Agent: Recommends optimal vendor mix for cost, risk, and performance
Spend Control & Reconciliation Solution
End-to-end financial management connecting budgets, contracts, invoices, and reconciliations with full traceability and automated controls.
The Challenge
Organizations struggle with budget overruns, invoice discrepancies, and time-consuming reconciliation processes. Manual workflows across disconnected systems create errors, delays, and audit risks.
The QPOS Solution
Our Spend Control solution provides real-time budget visibility, automated reconciliation, and predictive analytics to keep spend under control while accelerating close processes.
Budget Management
- Hierarchical budget structures (portfolio → study → vendor → category)
- Contract-linked budget allocation with milestone tracking
- Real-time spend visibility with committed vs. actual reporting
- Budget reforecasting with AI-powered predictions
- Approval workflows for budget changes and reallocations
- Multi-currency support with automatic conversion
- Budget vs. actual variance alerts and escalations
Reconciliation Excellence
- Automated three-way matching (PO → Contract → Invoice)
- Exception management with root cause categorization
- Change order tracking and impact analysis
- Accrual automation based on milestone completion
- Payment approval routing with delegation rules
- Month-end close acceleration (80% faster)
- Audit trail for all financial transactions
AI-Powered Financial Intelligence
- Reconciliation Agent: Automatically matches invoices to contracts with 99.5% accuracy, flagging discrepancies for review
- Variance Explainer: Provides natural language explanations for budget variances with supporting evidence
- Forecast Agent: Predicts future spend based on historical patterns, pipeline, and contract commitments
- Anomaly Detector: Identifies unusual spending patterns and potential fraud indicators
- Cash Flow Optimizer: Recommends optimal payment timing to maximize working capital
- Audit Readiness Agent: Ensures all transactions have proper documentation, approvals, and support
Operations Excellence Solution
Streamline cross-functional operations with unified visibility, intelligent automation, and seamless collaboration across quality, procurement, and finance.
Operational Challenges We Solve
- Disconnected systems creating information silos
- Manual handoffs causing delays and errors
- Lack of visibility into end-to-end processes
- Duplicate data entry across multiple platforms
- Inconsistent processes across departments
- Difficulty tracking cross-functional initiatives
- Limited real-time reporting and analytics
- Slow response to operational issues
Unified Operations Platform
- Single source of truth across quality, procurement, and finance
- Automated workflows eliminating manual handoffs
- Real-time dashboards with drill-down analytics
- Integrated document and data management
- Standardized processes with configurable templates
- Cross-functional project and initiative tracking
- Mobile access for field and remote teams
- Predictive analytics for proactive management
Key Features
- Unified Workspace: Role-based dashboards providing personalized views of relevant information and tasks
- Process Orchestration: Automated workflows spanning quality, procurement, and finance with intelligent routing
- Collaboration Hub: Centralized communication, document sharing, and decision-making for cross-functional teams
- Real-time Analytics: Live dashboards tracking KPIs, trends, and predictive insights across operations
- Mobile Operations: Full-featured mobile apps for audits, inspections, approvals, and data entry
- Integration Hub: Connect existing systems (ERP, CTMS, eTMF, etc.) with seamless data flow
- Change Management: Structured approach to process changes with impact analysis and training
- Continuous Improvement: Built-in analytics identifying optimization opportunities
CAPA Excellence Solution
Transform CAPA from a compliance burden to a strategic quality improvement engine with AI-powered root cause analysis and closed-loop effectiveness verification.
The CAPA Challenge
Most organizations struggle with slow CAPA closure, ineffective corrective actions, and repeat findings. Traditional CAPA systems focus on documentation rather than actual problem-solving.
CAPA Excellence Approach
Our AI-powered CAPA solution guides teams through structured root cause analysis, suggests effective corrective actions based on historical success, and verifies effectiveness through data-driven metrics.
Root Cause Analysis
- Multiple RCA methodologies (5 Whys, Fishbone, Fault Tree, etc.)
- AI-powered root cause suggestions based on similar issues
- Structured investigation templates and checklists
- Evidence collection and photo documentation
- Cross-functional collaboration on complex investigations
- Impact analysis across products and processes
- Root cause validation before CAPA assignment
Corrective Action Management
- Action effectiveness scoring based on historical data
- Automatic linkage to SOPs requiring updates
- Training assignment for personnel-related CAPAs
- Vendor notification for supplier-related issues
- Project management for complex multi-step CAPAs
- Resource allocation and capacity planning
- Milestone tracking with automated reminders
AI Agents for CAPA Excellence
- Finding Classification Agent: Automatically categorizes issues by type, severity, and regulatory requirement
- Root Cause Advisor: Suggests potential root causes using ML analysis of historical CAPA data
- Impact Analysis Agent: Identifies all affected products, processes, documents, and training records
- Action Effectiveness Predictor: Scores proposed corrective actions based on past success rates
- Repeat Finding Detector: Identifies patterns indicating ineffective CAPAs or systemic issues
- CAPA Prioritization Agent: Recommends investigation sequence based on risk and resource availability
Foundation Bundle
Perfect for organizations starting their Q²POS journey — core quality and procurement capabilities with AI-powered workflows.
What's Included
-
✓ Quality Management System (QMS)
Document control, version management, approval workflows, and audit trails -
✓ Learning Management System (LMS)
Training management, competency tracking, and SOP-linked curriculum -
✓ Audit Management
Internal audits, external inspections, finding tracking, and mobile execution -
✓ CAPA Management
Root cause analysis, corrective actions, and effectiveness verification -
✓ Basic Procurement
RFP management, vendor qualification, and contract tracking -
✓ Core AI Agents (5 included)
Finding Classifier, RCA Advisor, Training Gap Analyzer, Document Assistant, Audit Planner
• Scalable storage options
• Email support
• Standard integrations
• Quarterly training sessions
Growth Bundle
Scale your Q²POS implementation with advanced vendor oversight and financial reconciliation capabilities — ideal for growing organizations.
Everything in Foundation, Plus:
-
✓ Advanced Vendor Management
Vendor scorecards, risk scoring, performance analytics, and audit management -
✓ Financial Reconciliation
Budget management, invoice reconciliation, variance analysis, and forecasting -
✓ Change Control Management
Cross-functional change requests, impact analysis, and approval workflows -
✓ Advanced Analytics
Custom dashboards, trend analysis, and predictive insights -
✓ API Access
RESTful APIs for custom integrations and data exchange -
✓ Extended AI Agents (12 total)
+ Vendor Risk Scorer, Reconciliation Agent, Variance Explainer, Change Impact Analyzer, Forecast Agent, Performance Predictor, Contract Analyzer
• Enhanced storage capacity
• Phone & email support
• Premium integrations
• Monthly training sessions
• Dedicated CSM (Customer Success Manager)
Enterprise Bundle
Complete Q²POS platform with full control tower capabilities, unlimited users, and dedicated support — built for enterprise scale.
Everything in Growth, Plus:
-
✓ Cross-functional Control Tower
Unified executive dashboard across compliance, procurement, vendors, governance, and spend -
✓ Advanced Risk Management
Enterprise risk register, risk mitigation tracking, and portfolio-level risk analytics -
✓ Multi-site Management
Centralized oversight across multiple locations with local workflows -
✓ Advanced Security & Compliance
SSO, MFA, advanced audit logs, and dedicated security reviews -
✓ Custom Development
Tailored workflows, custom integrations, and bespoke reporting -
✓ HITL Services
Optional Human-in-the-Loop validation with Directors, Managers, and Analysts -
✓ All AI Agents (20+ included)
Complete AI agent suite + custom agent development for your specific needs
• Unlimited storage
• 24/7 premium support
• All integrations included
• Dedicated implementation team
• Executive business reviews
• Custom SLA agreements
• On-premise deployment options
Add-On Service Bundles
Enhance your QPOS platform with specialized professional services tailored to your needs across quality, procurement, and financial management.
Quality & Compliance Services
Expert support for quality management, inspection readiness, and compliance excellence.
- Inspection Readiness Assessment: Comprehensive gap analysis and remediation plan with mock audit support
- CAPA Excellence Program: Root cause analysis training, effectiveness evaluation, and continuous improvement coaching
- QMS Implementation Services: Document migration, workflow configuration, and user training for rapid deployment
- Audit Support Services: On-site audit facilitation, evidence compilation, and response preparation
- Training Development: Custom curriculum design, SOP-linked training content, and competency assessment programs
- Validation Services: Computer system validation (CSV) for 21 CFR Part 11 and EU Annex 11 compliance
Procurement & Vendor Services
Strategic vendor management and procurement optimization services.
- Vendor Qualification Program: End-to-end vendor assessment, due diligence, and qualification support
- RFP Development & Management: Custom RFP templates, vendor outreach, proposal evaluation, and scoring
- Vendor Risk Assessment: Comprehensive risk scoring model development and continuous monitoring setup
- Vendor Audit Services: On-site/remote audit execution, finding management, and corrective action follow-up
- Contract Optimization: Contract review, negotiation support, and terms & conditions improvement
- Procurement Process Design: Workflow optimization, governance framework, and policy development
Financial Management Services
Budget control, reconciliation, and financial process optimization expertise.
- Budget Structure Design: Multi-level budget framework development and allocation methodology
- Reconciliation Process Setup: Three-way matching logic, exception handling rules, and automation configuration
- Financial Controls Implementation: Approval workflows, segregation of duties, and audit trail configuration
- Month-End Close Acceleration: Process analysis, bottleneck identification, and automation opportunities
- Variance Analysis Framework: KPI definition, threshold setting, and escalation protocol development
- Financial Integration Services: ERP connectivity, data mapping, and synchronization setup
Integration & Custom Development
Technical services for seamless system integration and custom functionality.
- Enterprise System Integration: Custom API development for ERP, CTMS, eTMF, and legacy system connectivity
- Custom Workflow Development: Tailored approval routing, business rules, and automation logic
- Custom Reporting & Dashboards: Executive dashboards, operational reports, and analytics development
- Data Migration Services: Legacy data extraction, transformation, validation, and import
- Custom AI Agent Development: Specialized AI agents for unique business requirements
- Mobile App Customization: Custom mobile workflows for field operations and inspections
Human-in-the-Loop (HITL) Services
Expert validation and oversight combining AI automation with human expertise across all functional areas.
Service Tiers
- Analyst-Level HITL: Day-to-day validation of AI outputs, data quality checks, and routine decision support
- Manager-Level HITL: Complex case review, escalation handling, and process optimization recommendations
- Director-Level HITL: Strategic guidance, high-risk decisions, and regulatory compliance oversight
Coverage Areas
- CAPA root cause analysis validation and effectiveness review
- Vendor risk assessment verification and audit finding evaluation
- Financial reconciliation exception review and variance analysis
- Inspection readiness assessment and compliance gap validation
- Change control impact analysis and approval recommendations
ROI Analysis
Understand the financial impact and return on investment from implementing QPOS across your organization.
Cost Savings
- Manual Process Reduction: $180K-$450K annually from eliminating manual data entry, reconciliation, and reporting
- Faster Close Cycles: $75K-$150K annually from accelerated month-end close (5-10 days faster)
- Reduced Audit Findings: $200K-$500K annually avoiding regulatory observations and consent decree costs
- Vendor Optimization: $150K-$400K annually from better vendor negotiation and performance management
- Training Efficiency: $50K-$125K annually with automated curriculum and tracking
- CAPA Acceleration: $100K-$250K annually from faster investigation and closure
Risk Mitigation
- Regulatory Compliance: Avoid warning letters ($500K-$2M+ in remediation costs)
- Supply Chain Disruption: Early detection prevents $250K-$1M+ in emergency sourcing
- Budget Overruns: Proactive monitoring prevents 15-25% project cost overruns
- Vendor Quality Issues: Risk-based oversight reduces supplier-caused delays and defects
- Data Loss Prevention: Secure document control eliminates costly recreation efforts
- Audit Readiness: Continuous compliance reduces inspection preparation time by 70%
Typical Customer ROI
Implementation Costs
- Software subscription (Foundation: $1.5K/mo, Growth: $4K/mo, Enterprise: Custom)
- Implementation services (included in Enterprise, optional for others)
- Data migration and integration (varies by complexity)
- Training and change management (quarterly sessions included)
- Ongoing support (included in all bundles)
Productivity Gains
- 75% reduction in manual data entry and reporting
- 60% faster CAPA closure with AI-guided workflows
- 80% faster month-end close with auto-reconciliation
- 50% faster vendor qualification and selection
- 70% reduction in inspection preparation time
- 90% faster document approval cycles
Mid & Large Pharma Pricing
Enterprise deployment across multiple sites, therapeutic areas, and geographies with full Q²POS traceability and dedicated support.
Enterprise Package
Custom pricing based on number of sites, users, and deployment scope
Platform Access
- ✓ Full Q²POS Traceability Platform
- ✓ Unlimited QMS, LMS, CAPA, Audit modules
- ✓ Complete vendor and procurement suite
- ✓ Budget & reconciliation across all studies
- ✓ All AI agents and workflows
- ✓ Multi-site, multi-region deployment
Services Included
- ✓ Dedicated implementation team
- ✓ Computer System Validation (CSV)
- ✓ Legacy data migration
- ✓ ERP & CTMS integrations
- ✓ Executive dashboards & custom reports
- ✓ 24x7 support with dedicated CSM
Typical Enterprise Deployment
- Multi-site rollout (3-20+ facilities globally)
- 500-5000+ users across quality, procurement, finance
- Integration with SAP, Oracle, Veeva, eTMF/CTMS
- Custom AI agent development for unique workflows
- Dedicated HITL service teams (optional)
- White-glove onboarding and change management
ROI for Mid-Large Pharma
- $5-15M annual cost avoidance through better spend control
- 70% reduction in audit preparation time across all sites
- 50% faster vendor selection and qualification
- 60% reduction in month-end close time organization-wide
- Improved inspection outcomes with unified evidence
- Typical payback period: 12-18 months
Small Biopharma Pricing
Right-sized deployment for emerging companies — start with core quality and procurement, scale as you grow through clinical development.
Growth Package
Flexible pricing that scales with your clinical development pipeline
Starter Tier
- ✓ Up to 25 users
- ✓ QMS, LMS, CAPA, Audit modules
- ✓ Basic vendor management
- ✓ Budget tracking for 2-3 studies
- ✓ 5 AI agents included
- ✓ Email support (business hours)
Growth Tier
- ✓ Up to 75 users
- ✓ All Starter features plus:
- ✓ Full vendor oversight & scorecards
- ✓ Budget reconciliation & variance analysis
- ✓ 15 AI agents + custom workflows
- ✓ Phone/email support + dedicated CSM
Perfect for Small Biopharma
- Single-site or virtual organizations (20-100 employees)
- 1-5 active clinical studies in Phase 1-3
- 5-15 active vendors (CROs, labs, suppliers)
- Preparing for first FDA or EMA inspection
- Need to professionalize quality and procurement
- Limited IT resources for system implementation
ROI for Small Biopharma
- $150-500K annual cost avoidance on vendor spend
- 3-5 weeks faster vendor selection and qualification
- Inspection-ready in days instead of weeks
- 50% reduction in CAPA investigation time
- Faster study startup with streamlined vendor onboarding
- Typical payback period: 6-12 months
Service Providers Pricing
CRO, CDMO, and testing lab configurations with multi-client support, white-label options, and client portal access.
Service Provider Package
Multi-tenant architecture with client-specific portals and white-label branding
Base Platform
- ✓ Multi-tenant architecture
- ✓ Up to 10 client workspaces
- ✓ Client portal access & reporting
- ✓ QMS, vendor, budget modules
- ✓ White-label branding options
- ✓ Up to 100 internal users
Add-On Pricing
- Additional clients: Contact for pricing
- Extra users: Contact for pricing
- Client portal: Included
- HITL services: Variable pricing
CRO / CDMO Features
- Client-specific workspaces with data segregation
- Study/project budget tracking per sponsor
- Vendor qualification shared across clients (configurable)
- Client portal for real-time visibility into quality events
- Audit trail per client for regulatory inspections
- White-label option to match your brand
Value Proposition for Service Providers
- Differentiate with advanced QMS and AI capabilities
- Client transparency increases trust and retention
- Reduce overhead with automated quality processes
- Win more bids with inspection-ready documentation
- Scale client onboarding without linear cost increases
- Typical ROI: 40-60% reduction in quality overhead
Partners Pricing
Channel partner and systems integrator programs with co-selling opportunities, implementation support, and revenue sharing.
Partner Programs
Choose the partnership model that aligns with your business strategy
Referral Partner
Revenue share on closed deals
- ✓ Lead registration and protection
- ✓ Co-branded marketing materials
- ✓ Partner portal access
- ✓ Deal registration system
- ✓ Quarterly revenue reports
Implementation Partner
Revenue share + services revenue
- ✓ All Referral Partner benefits plus:
- ✓ Implementation certification training
- ✓ Services delivery toolkit
- ✓ Pre-sales technical support
- ✓ Keep 100% of services revenue
- ✓ Priority support escalation
Strategic Partner
White-label or OEM arrangements
- ✓ All Implementation Partner benefits plus:
- ✓ White-label branding options
- ✓ Custom feature development
- ✓ Dedicated partner success manager
- ✓ Co-development opportunities
- ✓ Joint go-to-market strategy
Partner Benefits
- Protected territories (for qualified partners)
- NFR licenses for demo and internal use
- Sales and technical training programs
- Marketing development funds (MDF)
- Co-marketing and event sponsorships
- Partner advisory council participation
Ideal Partner Profiles
- Life sciences consulting firms
- Quality and regulatory advisory practices
- Systems integrators (ERP, QMS, eTMF)
- Managed service providers for pharma/biotech
- Technology resellers in life sciences
- Specialized pharma software vendors
Partner Requirements
- Established presence in pharmaceutical/biotech industry
- Minimum 2 certified QPOS professionals (training provided)
- Commitment to minimum deal registrations (varies by tier)
- Professional services capability (for Implementation Partners)
- Active client base in target market segments
- Alignment with QPOS values and customer success focus
Customer Case Studies
Real-world success stories showing how organizations transformed their quality, procurement, and financial operations with QPOS.
Global Biotech Company: Achieving Inspection Readiness in 90 Days
Industry: Biopharmaceutical Manufacturing | Size: 2,500 employees | Challenge: Pending FDA Pre-Approval Inspection
With an FDA PAI scheduled in 90 days, this biotech company had disconnected quality systems, incomplete training records, and ineffective CAPA processes. Using QPOS, they achieved full inspection readiness and received zero 483 observations.
- Results: Zero FDA 483 observations on first PAI
- Timeline: 90 days from implementation to inspection
- Key Wins: Consolidated 4 systems into 1, trained 2,500 employees, closed 45 open CAPAs
- ROI: Avoided estimated $2M+ in remediation costs
Pharmaceutical CRO: Vendor Oversight Transformation
Industry: Contract Research Organization | Size: 800 employees | Challenge: Managing 200+ vendors with manual processes
This CRO struggled with reactive vendor management, inconsistent oversight, and no visibility into vendor performance trends. QPOS provided real-time risk scoring and proactive monitoring across their entire vendor portfolio.
- Results: 65% improvement in on-time delivery, 80% reduction in quality issues
- Efficiency: 50% faster vendor qualification, automated scorecard updates
- Risk Reduction: Early detection prevented 3 major supply chain disruptions
- Cost Savings: $1.2M annually from optimized vendor performance
Medical Device Manufacturer: Financial Control & Reconciliation
Industry: Medical Devices | Size: 1,200 employees | Challenge: Budget overruns and time-consuming reconciliations
With clinical studies running 15-20% over budget and month-end close taking 12 days, this manufacturer needed better financial controls. QPOS automated reconciliation and provided real-time budget visibility.
- Results: 80% faster month-end close (12 days → 2.5 days)
- Budget Control: Reduced budget variances from 18% to 3%
- Accuracy: 99.5% automated invoice matching, 95% fewer manual corrections
- Savings: $450K annually from process efficiency, $1.8M from budget control
Whitepapers & Research
In-depth technical papers and industry research on quality management, vendor oversight, and financial controls in regulated industries.
The Q²POS Traceability Framework
32 pages | Published Q1 2025
Comprehensive guide to implementing end-to-end traceability from SOP updates to invoice reconciliation. Includes implementation roadmap, best practices, and measurable outcomes.
AI + HITL in Regulated Industries
28 pages | Published Q4 2024
Explore how AI agents combined with Human-in-the-Loop validation are transforming quality management, vendor oversight, and financial reconciliation in FDA/EMA-regulated environments.
Vendor Risk Management in Clinical Trials
24 pages | Published Q3 2024
Best practices for risk-based vendor oversight including qualification, performance monitoring, and proactive intervention strategies. Based on analysis of 500+ vendor relationships.
Financial Controls for Life Sciences
20 pages | Published Q2 2024
Implementing automated reconciliation and budget controls in pharmaceutical and biotech organizations. Includes ROI calculator and implementation checklist.
Webinars & Events
Join live sessions and watch on-demand recordings covering quality management, vendor oversight, AI implementation, and industry best practices.
Inspection Readiness: A Proactive Approach
February 18, 2025 | 2:00 PM EST | 60 minutes
Learn how leading organizations maintain continuous inspection readiness using AI-powered gap detection, automated evidence collection, and mock audit simulations.
- Building a continuous monitoring framework
- Using AI to predict inspection findings
- Implementing mock audit programs
- Creating war room protocols
AI-Powered Vendor Risk Scoring
Recorded January 2025 | 45 minutes
Discover how AI agents continuously monitor vendor performance across quality, financial, and operational dimensions with real-time risk scoring.
Automated Financial Reconciliation
Recorded December 2024 | 50 minutes
Learn how to implement three-way matching, automated accruals, and variance analysis to accelerate month-end close by 80%.
CAPA Excellence with AI-Guided RCA
Recorded November 2024 | 40 minutes
Transform CAPA from compliance burden to strategic quality tool using AI-powered root cause analysis and effectiveness prediction.
Building a Cross-functional Control Tower
Recorded October 2024 | 55 minutes
Create unified visibility across quality, procurement, vendors, governance, and spend with executive-level dashboards and analytics.
Implementation Guides
Step-by-step guides for implementing QPOS modules, integrating with existing systems, and achieving rapid time-to-value.
QMS Implementation: 30-Day Quick Start
Launch your Quality Management System in 30 days with this proven implementation roadmap.
- Week 1: System configuration, user setup, document templates
- Week 2: Document migration, approval workflows, training
- Week 3: Pilot with core team, refinement, integration testing
- Week 4: Full rollout, change management, go-live support
Vendor Management Setup Guide
Configure vendor lifecycle management, risk scoring, and performance tracking in 45 days.
- Phase 1: Vendor data migration and categorization
- Phase 2: Risk scoring model configuration
- Phase 3: Scorecard design and KPI setup
- Phase 4: Audit workflows and training
Financial Reconciliation Quick Start
Implement automated reconciliation and budget tracking in 21 days.
- Week 1: Chart of accounts mapping, budget structure
- Week 2: Contract import, reconciliation rules, matching logic
- Week 3: Integration with ERP, testing, user training
API Integration Cookbook
Technical guide for integrating QPOS with ERP, CTMS, eTMF, and other enterprise systems.
- Authentication and authorization patterns
- Common integration scenarios with code samples
- Error handling and retry strategies
- Performance optimization best practices
About AuraGXP
Pioneering the future of quality, procurement, and financial management in regulated industries through AI-powered intelligence and unified traceability.
Our Mission
To transform how life sciences organizations manage quality, vendors, and spend by creating complete traceability from SOP updates to invoice reconciliation — eliminating silos and enabling data-driven decision-making.
Our Story
Founded by veterans of the pharmaceutical and biotech industries, QPOS was born from a simple observation: organizations were drowning in disconnected systems that created compliance risks, operational inefficiencies, and missed opportunities for improvement.
After seeing countless companies struggle with FDA warning letters due to training gaps, vendor quality issues causing clinical trial delays, and budget overruns from poor financial controls, our founders set out to build a unified platform that would solve these challenges holistically.
Core Values of AuraGXP
Our values guide every decision, every partnership, and every solution we deliver.
1. Own Outcomes with Accountability
Do what's right. Deliver what matters.
We take responsibility for our actions, uphold integrity, and drive results through ethical, transparent decisions.
2. Think and Act with Quality by Design
Build excellence from the start.
We embed quality, compliance, and business acumen into every process—from concept to commercialization, guided by ICH requirements.
3. Focus Relentlessly on the Customer
Our customer's success defines ours.
We listen, partner, and deliver value that exceeds expectations and drives shared success.
4. Lead with Human, Assisted by AI
Human wisdom enhanced by gen technology.
We combine deep expertise with AI innovation to enhance quality, readiness, and confident decision-making.
5. Embrace Change with Adaptability
Evolve. Improve. Excel.
We stay agile, turning challenges into opportunities for innovation and continuous improvement.
6. Build and Nurture Trusting Relationships
Trust is our foundation.
We protect confidentiality, act with integrity, and strengthen every partnership through transparency and respect.
Our Team
Led by industry veterans with decades of experience in pharmaceutical manufacturing, quality systems, procurement, and enterprise software.
Tony Stark, PhD
Former VP of Quality at leading biopharmaceutical company with 20+ years in quality systems, regulatory compliance, and inspection readiness. Led quality organizations through multiple successful FDA inspections and consent decree remediation.
Education: PhD in Pharmaceutical Sciences, MBA
Captain America
Former Chief Architect at enterprise software company with expertise in AI/ML, cloud platforms, and regulated system validation. Built multiple FDA 21 CFR Part 11 compliant systems serving 100K+ users.
Education: MS Computer Science, BS Engineering
Iron Fist
20+ years in procurement and vendor management, previously led global outsourcing function at top 10 pharma company. Expert in vendor qualification, risk management, and supplier relationship optimization.
Education: MBA Supply Chain, BA Economics
Ant Man
Former Finance VP at medical device company, specializing in clinical trial budgeting, vendor spend management, and financial controls. Led implementation of automated reconciliation saving $5M+ annually.
Education: CPA, MBA Finance, BS Accounting
Advisory Board
- Wonder Woman — Former FDA CDER Director, expert in pharmaceutical quality and compliance
- Doctor Strange — Former SVP Global Operations at Fortune 500 pharma, 30+ years industry experience
- Black Panther — Biotech CEO and serial entrepreneur, 5 successful exits in life sciences
- Green Lantern — Former Big 4 Partner specializing in FDA remediation and quality systems
Success Metrics
Real data from QPOS customers showing measurable improvements in quality, procurement, and financial operations.
Quality & Compliance Metrics
- 85% reduction in repeat audit findings year-over-year
- 75% reduction in training-related compliance findings
- 90% faster document approval cycles
- 70% reduction in inspection preparation time
- 100% pass rate on first regulatory inspection for new customers
- 95% CAPA effectiveness rate (preventing recurrence)
Procurement & Vendor Metrics
- 50% faster vendor qualification and selection
- 65% improvement in vendor on-time delivery
- 80% reduction in vendor quality issues
- Real-time risk scoring preventing 3-5 supply disruptions annually
- 40% reduction in vendor audit costs through risk-based approach
- $150K-$400K annual savings from vendor optimization
Financial Control Metrics
- 80% faster month-end close (average 12 days → 2.5 days)
- 99.5% automated invoice matching accuracy
- Budget variance reduced from 18% to 3% average
- 95% reduction in manual reconciliation effort
- $180K-$450K annual savings from process automation
- 15-25% prevention of budget overruns through proactive monitoring
Operational Efficiency Metrics
- 75% reduction in manual data entry across functions
- 50% reduction in cross-functional cycle times
- Complete visibility replacing 4-7 disconnected systems
- 90% user adoption rate within 60 days
- 85% reduction in time spent on compliance reporting
- Real-time decision-making replacing weekly/monthly reviews
Consulting Services
Strategic advisory and assessment services that work with any quality, procurement, or financial system — delivered by GxP and operational excellence experts.
Inspection Readiness Assessment
Comprehensive gap analysis and remediation planning for FDA, EMA, and other regulatory inspections
- Current state assessment against 21 CFR Parts 11, 210, 211, 820 and EU Annex 11
- Documentation review across QMS, training records, and audit trails
- Gap identification with risk-based prioritization
- Remediation roadmap with timelines and resource requirements
- Mock inspection exercises and interview preparation
- Evidence compilation strategy and presentation coaching
Vendor Risk Assessment & Qualification Strategy
Risk-based vendor qualification framework and strategic sourcing advisory
- Vendor qualification framework design aligned with ICH Q9 and Q10
- Risk-based qualification criteria and decision trees
- Strategic sourcing analysis and vendor market landscape
- Due diligence methodology and assessment protocols
- Vendor tiering and oversight frequency recommendations
- RFP strategy and competitive evaluation frameworks
Budget Structure & Reconciliation Framework
Multi-level budget architecture and reconciliation process design
- Study/project budget structure and WBS design
- Budget allocation methodology and approval workflows
- Three-way matching process design and tolerance thresholds
- Variance analysis framework and escalation protocols
- Accrual and prepayment reconciliation procedures
- Financial close checklist and month-end optimization
Process Optimization & Gap Analysis
Current state assessment and future state process design
- End-to-end process mapping and value stream analysis
- Bottleneck identification and cycle time optimization
- Automation opportunity assessment and ROI analysis
- Workflow standardization and best practice recommendations
- Change management impact assessment
- KPI definition and performance measurement frameworks
Regulatory Compliance Advisory
Regulatory interpretation and compliance strategy for GxP operations
- Regulatory requirement interpretation (FDA, EMA, PMDA, etc.)
- Compliance gap assessment and remediation strategy
- Regulatory submission support and documentation review
- Inspection response strategy and CAPA development
- Quality agreement and contract compliance review
- Global harmonization and multi-site compliance strategy
Digital Transformation Roadmap
Technology assessment and phased implementation planning
- Current system landscape assessment and integration analysis
- Technology selection criteria and vendor evaluation
- Phased implementation roadmap with quick wins identification
- Change management and organizational readiness assessment
- Business case development and ROI modeling
- Success metrics and performance tracking frameworks
GMP and GCP Audit Services
Comprehensive audit services conducted by certified GMP and GCP auditors with extensive regulatory experience
- Internal GMP audits for manufacturing and quality systems
- GCP audits for clinical trial sites and investigator oversight
- Vendor and supplier qualification audits
- Pre-approval inspection (PAI) readiness audits
- Mock regulatory inspections with detailed gap analysis
- Computer System Validation (CSV) audits for 21 CFR Part 11 compliance
- Data integrity audits and ALCOA+ compliance verification
- Quality agreement compliance audits
- CAPA effectiveness verification audits
- Audit report preparation with risk-based findings and recommendations
Managed Services
Ongoing operational support and continuous monitoring services — expert teams that become an extension of your quality, procurement, and finance organizations.
Human-in-the-Loop (HITL) Validation Services
Expert validation combining AI automation with human oversight across all functional areas
- Analyst-Level: Daily validation of AI outputs, data quality checks, routine exception review
- Manager-Level: Complex case adjudication, process optimization, trend analysis
- Director-Level: High-risk decision approval, strategic guidance, regulatory interpretation
- CAPA root cause analysis validation and effectiveness review
- Vendor risk assessment verification and audit finding evaluation
- Financial reconciliation exception review and variance analysis
Ongoing CAPA & Audit Support
Continuous quality event management and audit readiness maintenance
- CAPA investigation support and root cause analysis facilitation
- Effectiveness check execution and closure verification
- Audit finding tracking and CAPA response development
- Internal audit execution and reporting
- Continuous inspection readiness and evidence maintenance
- Quality metrics monitoring and trending analysis
Vendor Oversight & Performance Monitoring
Continuous vendor risk monitoring and performance scorecard management
- Ongoing vendor risk scoring and alert management
- Vendor audit scheduling, execution, and follow-up
- Performance scorecard updates and trend analysis
- Contract compliance monitoring and amendment tracking
- Vendor CAPA response evaluation and closure verification
- Continuous vendor landscape monitoring and market intelligence
Financial Reconciliation Operations
Ongoing reconciliation execution and variance investigation services
- Monthly reconciliation execution (PO-Receipt-Invoice matching)
- Exception investigation and resolution support
- Variance analysis and commentary preparation
- Accrual calculation and reversal processing
- Supporting documentation compilation and retention
- Month-end close support and certification
Quality System Maintenance
Continuous QMS upkeep and document control support
- Controlled document review and approval coordination
- Training record maintenance and retraining tracking
- Change control execution and documentation support
- Deviation and OOS investigation assistance
- Quality agreement maintenance and compliance monitoring
- Annual product review (APR) preparation and execution
Continuous Compliance Monitoring
Proactive compliance surveillance and regulatory intelligence
- Regulatory change monitoring (FDA, EMA, ICH guidelines)
- Impact assessment and gap analysis for new requirements
- Warning letter and 483 observation analysis
- Industry trend monitoring and best practice identification
- Compliance dashboard management and reporting
- Proactive risk identification and mitigation recommendations
Service Level Options
Standard Coverage
Business hours support (8x5) with next-business-day response times
Extended Coverage
Extended hours (12x6) with same-day response for urgent matters
24x7 Coverage
Around-the-clock support for global operations and critical systems
Implementation Services
End-to-end deployment services for quality, procurement, and financial systems — from legacy migration to validation to user adoption.
QMS/LMS Implementation & Migration
Complete quality system deployment with legacy data migration
- Requirements gathering and system configuration
- Document taxonomy and metadata structure design
- Legacy document assessment, cleansing, and migration
- Workflow and approval routing configuration
- Training curriculum development and SOP linkage
- User acceptance testing (UAT) and go-live support
Procurement System Configuration
Vendor management and procurement platform setup
- Vendor master data structure and taxonomy
- RFP/RFI template library and workflow setup
- Contract lifecycle management configuration
- Vendor scorecard and risk scoring model implementation
- Approval workflows and segregation of duties
- Integration with quality and financial systems
Financial Integration & Setup
Budget, reconciliation, and ERP integration services
- Chart of accounts mapping and master data synchronization
- Budget structure configuration and approval workflows
- Three-way matching logic and tolerance setup
- ERP integration (SAP, Oracle, NetSuite, Workday)
- Variance analysis and reporting configuration
- Financial close checklist and automation setup
User Training & Change Management
Comprehensive user enablement and organizational change support
- Role-based training curriculum development
- Train-the-trainer programs for internal champions
- User guides, quick reference cards, and job aids
- Change impact assessment and stakeholder mapping
- Communication strategy and rollout planning
- Post-go-live reinforcement and support
Validation Services (CSV)
Computer system validation for 21 CFR Part 11 and EU Annex 11 compliance
- System risk assessment and validation approach
- User Requirements Specification (URS) development
- Functional Requirements Specification (FRS)
- Installation, Operational, Performance Qualification (IQ/OQ/PQ)
- Requirements Traceability Matrix (RTM)
- Validation summary report and ongoing compliance
Go-Live Support & Hypercare
Intensive support during and after system go-live
- Cutover planning and execution support
- On-site/remote support during go-live weekend
- Issue triage and rapid resolution
- 30-60-90 day hypercare coverage
- User feedback collection and quick fixes
- Knowledge transfer to internal support teams
Implementation Approach
Phase 1: Discovery
Requirements gathering, process mapping, and solution design (2-4 weeks)
Phase 2: Build
System configuration, data migration, and integration development (4-8 weeks)
Phase 3: Validate
Testing, validation execution, and issue remediation (3-6 weeks)
Phase 4: Deploy
Training, cutover, go-live, and hypercare support (2-4 weeks)
Typical Timeline: 90-180 days from kickoff to full production deployment
Cross-Functional Control Tower
Unified executive dashboard providing real-time visibility across Quality Compliance, Quality Assurance, Procurement, Oversight, and Spend — enabling data-driven decisions and proactive risk management.
Integrated Dashboard Views
- Real-time compliance status across all GxP operations
- Quality metrics including CAPA, audit findings, and deviations
- Procurement pipeline and vendor performance scorecards
- Budget vs. actual spend with variance analysis
- Risk heat maps across quality, vendor, and financial dimensions
- Change control impact assessment and approval tracking
Executive Analytics
- Portfolio-level quality trends and KPI tracking
- Vendor risk scoring and performance trends
- Financial forecasting and budget utilization
- Inspection readiness score with evidence completeness
- Cross-functional resource allocation and capacity planning
- Predictive analytics for quality events and cost overruns
Operational Insights
- Drill-down capabilities from executive view to transaction detail
- Automated alerts for critical events and threshold breaches
- Trend analysis across time, location, and organizational units
- Benchmarking against industry standards and internal targets
- Root cause analysis linking quality events to processes and vendors
- Audit trail and compliance evidence at your fingertips
Quality Compliance
Comprehensive quality compliance framework connecting SOPs, controlled documents, regulatory requirements, learning management, change control, and risk management into a traceable system.
SOP Management
- Centralized SOP repository with version control
- Automated approval workflows and electronic signatures
- SOP effectiveness checks and periodic reviews
- Impact analysis for SOP changes across organization
- Integration with training and competency tracking
- AI-powered SOP authoring assistance and compliance checking
Controlled Documents
- Document lifecycle management from creation to retirement
- Metadata-driven taxonomy and search capabilities
- Automated distribution and acknowledgment tracking
- Version comparison and change tracking
- Electronic signature compliance (21 CFR Part 11)
- Integration with quality events and CAPA investigations
Regulatory Impact Assessment
- Regulatory requirement tracking (FDA, EMA, ICH, etc.)
- Impact analysis for new and revised regulations
- Gap assessment against current processes and documentation
- Regulatory intelligence and change notifications
- Compliance roadmap and remediation planning
- Warning letter and 483 observation monitoring
Learning Management
- SOP-linked training curriculum and competency tracking
- Automated training assignment based on role and responsibilities
- Training effectiveness assessment and validation
- Retraining triggers from SOP changes and quality events
- Learning paths for GxP compliance and specialized roles
- Training record integration with qualification and audits
Change Management
- Cross-functional change request and approval workflows
- Impact analysis across quality, operations, and documentation
- Risk assessment and mitigation planning for changes
- Change implementation tracking and verification
- Post-implementation review and effectiveness checks
- Integration with CAPA, deviations, and training systems
Risk Management
- Enterprise risk register with risk identification and categorization
- Risk assessment using FMEA, HACCP, and other methodologies
- Mitigation strategy development and implementation tracking
- Residual risk monitoring and continuous reassessment
- Risk-based decision making for quality and compliance
- Integration with quality events, audits, and vendor oversight
Quality Assurance
End-to-end quality assurance capabilities covering audit management, CAPA investigations, incident and event tracking, and inspection readiness — all powered by AI agents and traceable to root causes.
Audit Management
- Internal audit planning with risk-based scheduling
- External inspection and regulatory audit tracking
- Mobile-enabled audit execution with offline capabilities
- Finding categorization and severity assessment
- Automated CAPA generation from audit observations
- Audit metrics and trending analysis across sites and functions
CAPA (Corrective and Preventive Actions)
- Structured root cause analysis with multiple methodologies (5 Why, Fishbone, etc.)
- Impact assessment across products, processes, and documentation
- Corrective action planning with resource allocation
- Preventive action identification to address systemic issues
- Effectiveness verification with metrics and validation
- Integration with training, SOP updates, and vendor management
Incidents & Events
- Deviation tracking and investigation workflows
- Out-of-specification (OOS) and out-of-trend (OOT) management
- Product complaints and adverse event reporting
- Incident classification and regulatory reporting requirements
- Investigation documentation with complete audit trails
- Trend analysis and early warning systems for recurring issues
Inspections & Regulatory Readiness
- Continuous inspection readiness monitoring and scoring
- Evidence compilation and documentation management
- Mock inspection and gap assessment capabilities
- Regulatory submission support and response management
- Warning letter and 483 observation tracking and remediation
- Pre-inspection preparation and post-inspection follow-up
AI Agents for Quality Assurance
- Finding Classification Agent: Automatically categorizes audit findings by type, severity, and regulatory requirement
- Root Cause Advisor: Suggests potential root causes using historical data and machine learning patterns
- Impact Analysis Agent: Identifies all affected products, processes, documents, and training records
- CAPA Effectiveness Predictor: Assesses likelihood of corrective action success based on past performance
- Repeat Finding Detector: Identifies patterns across audits to prevent recurring issues
- Inspection Readiness Agent: Continuously monitors compliance status and evidence completeness
Procurement
Streamlined procurement processes covering RFI/RFP management, supplier and vendor due diligence, selection workflows, and contract lifecycle management — all integrated with quality and spend controls.
RFI / RFP Management
- AI-powered RFP generation from requirements and templates
- Automated vendor discovery and market intelligence
- RFI/RFP distribution and response tracking
- Proposal analysis with AI-assisted scoring and comparison
- Collaborative evaluation with cross-functional teams
- Decision documentation and audit trail
Supplier / Vendor Due Diligence
- Comprehensive due diligence questionnaires and checklists
- Financial stability assessment and credit checks
- Quality system evaluation and certification verification
- Regulatory compliance screening (FDA, EMA, ISO certifications)
- Reference checks and past performance validation
- Risk assessment across quality, financial, and operational dimensions
Vendor Selection & Qualification
- Multi-criteria evaluation with weighted scoring
- Qualification workflows with approval routing
- On-site audit scheduling and execution support
- Quality agreement negotiation and approval
- Vendor approval with role-based governance
- Integration with vendor master data and ERP systems
Contracts Management
- Contract lifecycle management from negotiation to renewal
- Automated contract authoring with template library
- Clause extraction and obligation tracking
- Contract approval workflows with legal review
- Milestone and deliverable tracking with payment linkage
- Contract amendment management with version control
- Auto-renewal notifications and renegotiation triggers
- Integration with budget management and financial reconciliation
AI Agents for Procurement Excellence
- RFP Generation Agent: Creates comprehensive RFPs from requirements using best practices and templates
- Vendor Discovery Agent: Identifies qualified suppliers based on capabilities and certifications
- Proposal Analysis Agent: Analyzes vendor proposals and identifies key differentiators
- Contract Analyzer: Extracts key terms, identifies risks, and ensures compliance
- Spend Forecasting Agent: Predicts future procurement needs based on historical patterns
Oversight
Comprehensive vendor oversight framework with performance scorecards, continuous vendor management, change control integration, and risk-based quality monitoring across your entire supply chain.
Vendor Scorecard
- Multi-dimensional performance metrics (quality, delivery, cost, innovation)
- Real-time scorecard updates with automated data collection
- KPI tracking with threshold alerts and escalations
- Trend analysis and performance benchmarking
- Customizable scoring models for different vendor categories
- Visual dashboards for executive and operational stakeholders
Vendor Management
- Ongoing vendor lifecycle management from qualification to retirement
- Periodic review and requalification workflows
- Vendor communication and collaboration portal
- Issue tracking and resolution management
- Performance improvement plans and corrective actions
- Vendor segmentation for risk-based oversight strategies
Change Control Integration
- Vendor-initiated change notification and impact assessment
- Cross-functional review of vendor changes
- Risk assessment for manufacturing and supplier changes
- Change approval workflows with quality agreement alignment
- Implementation verification and validation
- Post-change monitoring and performance tracking
Risk-Based Quality Oversight
- Continuous risk scoring across quality, financial, and operational dimensions
- Regulatory compliance monitoring (FDA, EMA, ISO certifications)
- Audit planning based on vendor risk profile and performance
- Deviation and CAPA tracking for supplier quality events
- Supply chain risk mapping and mitigation strategies
- Early warning systems for vendor performance degradation
- Quality agreement compliance monitoring and enforcement
- Supplier diversity and capacity risk assessment
AI Agents for Vendor Oversight
- Risk Scoring Engine: Continuously evaluates vendor risk using multiple data sources
- Performance Predictor: Forecasts vendor performance trends and identifies at-risk relationships
- Audit Planner: Creates risk-based audit schedules optimizing resource allocation
- Change Impact Analyzer: Assesses impact of vendor changes on quality and operations
- Early Warning Agent: Detects patterns indicating potential vendor issues
Spend Management
Comprehensive spend control and reconciliation covering budget planning, variance reporting, payment management, milestone tracking, invoice reconciliation, and integrated change management — all connected to quality and procurement.
Budget Planning
- Multi-level budget planning (portfolio, study, vendor, category)
- Contract-linked budget allocation and tracking
- Bottom-up and top-down budget development
- Budget templates and modeling scenarios
- Approval workflows with delegation and escalation
- Integration with procurement and contract management
Monthly Variance Reporting
- Automated budget vs. actual variance calculation
- Variance analysis by category, vendor, and time period
- Commentary capture and explanation documentation
- Trend analysis and year-over-year comparisons
- Executive summary dashboards with drill-down capabilities
- Automated variance report generation and distribution
Payments Management
- Payment approval workflows with multi-level authorization
- Payment scheduling aligned with contract terms
- Payment hold management for quality or contract issues
- Payment tracking and reconciliation to contracts
- Integration with ERP and accounts payable systems
- Payment audit trail and compliance reporting
Milestones & Invoice Reconciliation
- Milestone definition and tracking linked to contracts
- Deliverable verification and acceptance workflows
- Automated invoice-to-contract-to-PO matching (3-way reconciliation)
- Exception management and discrepancy resolution
- Accrual automation with milestone triggers
- Invoice approval routing and payment authorization
- Month-end close acceleration with automated reconciliations
Change Management & Financial Controls
- Change order tracking and budget impact analysis
- Contract amendment financial implications
- Budget reallocation workflows with approvals
- Forecasting updates based on change orders
- Financial controls and segregation of duties
- Audit trail for all financial transactions and changes
- Regulatory compliance (SOX, GxP financial controls)
AI Agents for Spend Intelligence
- Reconciliation Agent: Automatically matches invoices to contracts and identifies discrepancies
- Variance Analysis Agent: Explains budget variances and flags anomalies for investigation
- Forecasting Agent: Predicts future spend based on historical trends and pipeline
- Audit Readiness Agent: Ensures all transactions have proper documentation and approvals
- Cash Flow Optimizer: Recommends optimal payment timing based on terms and cash position
- Change Impact Agent: Assesses financial impact of scope and contract changes
Q²POS Framework
The Q²POS Framework represents a fundamental shift in how life sciences organizations manage quality, procurement, and financial operations — moving from disconnected silos to unified, traceable workflows.
What is Q²POS?
Q²POS stands for Quality Compliance, Quality Assurance, Procurement, Oversight, and Spend — the five critical pillars that must work together seamlessly for operational excellence in regulated industries.
Traditional approaches treat these as separate functions with different systems, processes, and data. The Q²POS Framework unifies them into a single, intelligent platform where every action is traceable across all dimensions.
SOPs, Controlled Documents, Regulatory Impact, Learning, Change Management, Risk Management
Audit, CAPA, Incidents & Events, Inspections
RFI/RFP Management, Supplier Due Diligence, Selection, Contracts
Vendor Scorecard, Vendor Management, Change Control, Risk-Based Quality
Budget Planning, Variance Reporting, Payments, Milestones, Invoice Reconciliation
Why Q²POS Matters
- Regulatory Compliance: Connect quality events to root causes, training gaps, and vendor issues with complete audit trails
- Operational Efficiency: Eliminate duplicate data entry and reconciliation between disconnected systems
- Financial Control: Link every dollar spent to contracts, milestones, quality agreements, and governance approvals
- Risk Management: Identify patterns and trends across quality, vendor performance, and financial variances
- Strategic Decisions: Make data-driven decisions with real-time visibility across all operational dimensions
- Inspection Readiness: Always-ready evidence showing complete traceability from findings to resolutions
Q²POS Traceability™
Q²POS Traceability™ is our proprietary approach to creating complete, auditable connections between every element of your quality, procurement, and financial operations — from regulatory requirements to final invoice reconciliation.
Quality → Compliance Traceability
- Regulatory requirements trace to SOPs and controlled documents
- SOP changes automatically trigger training assignments
- Training records link to competency assessments and audits
- Audit findings connect to root cause analysis and CAPA
- CAPAs trigger SOP updates, retraining, and vendor notifications
- Change controls map to all affected documents and training
Procurement → Vendor Traceability
- Procurement requirements trace to RFP generation and vendor discovery
- Vendor proposals link to evaluation criteria and scoring
- Selection decisions connect to due diligence documentation
- Contracts tie to quality agreements and compliance requirements
- Vendor performance data feeds into scorecards and risk scores
- Quality events trigger vendor CAPAs and contract reviews
Financial → Governance Traceability
- Budgets link to contracts, milestones, and approval workflows
- Purchase orders connect to quality agreements and vendor qualifications
- Invoices reconcile to contracts, deliverables, and payments
- Change orders trace to impact analysis and budget reforecasting
- Variances connect to root cause explanations and action plans
- Spend data ties to vendor performance and strategic sourcing
Cross-Functional Traceability Examples
- Quality Event → Financial Impact: Audit finding identifies training gap → Retraining required → CRO vendor engaged → Contract amendment → Budget impact → Variance explained
- Vendor Issue → Quality Impact: Vendor delivery delay → Quality agreement breach → Audit scheduled → Finding documented → CAPA initiated → Contract penalty applied → Scorecard updated
- Change Control → Complete Impact: SOP revision → Training reassignment → Vendor notification → Process validation → Documentation update → Cost impact → Budget reallocation
- Regulatory Change → End-to-End: New FDA guidance → Gap analysis → SOP updates → Training rollout → Vendor qualification changes → Contract amendments → Implementation costs tracked
AI + HITL Technology
Our unique combination of Artificial Intelligence and Human-in-the-Loop (HITL) expertise delivers the speed and consistency of automation with the judgment and regulatory knowledge of experienced professionals.
The Best of Both Worlds
AI excels at pattern recognition, data processing, and repetitive tasks. Humans excel at complex judgment, regulatory interpretation, and nuanced decision-making. QPOS combines both through intelligent orchestration.
Our AI agents handle routine analysis and automate workflows, while HITL experts validate critical decisions, handle edge cases, and provide strategic guidance — creating a system that's both efficient and trustworthy.
Automated analysis, classification, and recommendations for routine decisions
Each AI decision includes confidence score; low confidence triggers human review
Experts review flagged cases, complex scenarios, and high-risk decisions
Human feedback improves AI models over time, increasing automation rate
AI Agent Capabilities
- Finding Classification: Categorize audit observations, deviations, and quality events by type and severity
- Root Cause Advisor: Suggest potential root causes using historical CAPA data and ML pattern analysis
- Impact Analysis: Identify all affected products, processes, documents, and training records automatically
- Vendor Discovery: Find qualified suppliers based on capabilities, certifications, and performance data
- Risk Scoring: Continuously evaluate vendor and quality risk across multiple dimensions
- Reconciliation: Automatically match invoices to contracts and flag discrepancies for review
- Variance Analysis: Explain budget variances and identify anomalies requiring investigation
HITL Validation Services
- Analyst-Level: Daily validation of AI outputs, data quality checks, routine exception review
- Manager-Level: Complex case adjudication, process optimization, trend analysis and recommendations
- Director-Level: High-risk decision approval, strategic guidance, regulatory interpretation
- Subject Matter Experts: Former FDA inspectors, quality directors, and procurement executives
- GxP Compliance: All HITL experts trained in cGMP, GCP, and regulated industry requirements
- Flexible Engagement: Dedicated resources, shared service center, or on-demand support models
AI + HITL in Action: CAPA Investigation Example
- Step 1 - AI: Finding Classification Agent categorizes audit observation as "Critical - Training Gap"
- Step 2 - AI: Root Cause Advisor analyzes past similar findings and suggests 3 potential root causes with confidence scores
- Step 3 - HITL: Quality Manager reviews AI suggestions, selects root cause, adds regulatory context
- Step 4 - AI: Impact Analysis Agent identifies all affected personnel, SOPs, and training records
- Step 5 - AI: System generates corrective action plan with training reassignments and SOP update workflow
- Step 6 - HITL: Quality Director approves CAPA plan and effectiveness check criteria before implementation
- Result: CAPA closure in 18 days vs. 45-day average — 60% faster with complete audit trail and regulatory confidence
Measurable Outcomes
QPOS delivers quantifiable improvements across quality, operational efficiency, vendor performance, and financial control — with metrics that matter to executives, regulators, and operational teams.
Quality & Compliance Outcomes
- Inspection Readiness: Days instead of weeks to compile evidence for regulatory inspections
- CAPA Closure Time: 60% reduction in average time from finding to verified effectiveness
- Repeat Findings: 85% reduction in year-over-year recurring audit observations
- Training Completion: 95%+ on-time completion with automated assignment and tracking
- SOP Currency: 100% compliance with periodic review schedules and change control
- Deviation Response: 50% faster investigation and resolution with AI-guided workflows
Vendor & Procurement Outcomes
- Vendor Selection: 50% faster qualification with AI-powered RFP and automated evaluation
- Vendor Performance: Real-time risk scoring enabling proactive issue resolution
- Contract Compliance: 100% alignment between quality agreements and operational reality
- Audit Efficiency: Risk-based vendor audits optimizing quality resources
- Sourcing Decisions: Data-driven vendor strategy based on comprehensive scorecards
- Supplier Diversity: Better visibility enabling strategic supplier development
Financial & Operational Outcomes
- Month-End Close: 80% faster with automated reconciliations and variance analysis
- Reconciliation Accuracy: 99.9% with AI-validated invoice matching
- Budget Variance: Early detection of overruns enabling proactive management
- Cash Flow: Optimized payment timing based on terms and working capital
- Cost Avoidance: Millions in savings through better spend control and vendor management
- Productivity Gains: Quality, procurement, and finance teams freed for strategic work
Customer Success Story: Mid-Size Biopharma
Challenge: Disconnected quality and procurement systems creating compliance risks and operational inefficiencies
Implementation Results (90 Days)
- FDA inspection preparation reduced from 4 weeks to 3 days with always-ready evidence
- CAPA investigations averaging 18 days vs. 45-day baseline — 60% improvement
- Vendor selection for new CRO completed in 6 weeks vs. 6-month historical average
- Month-end close reduced from 15 days to 3 days with automated reconciliations
- Budget variance reporting automated with AI-generated explanations
- Complete traceability from SOP changes to vendor contracts to financial impact
Unified Platform
QPOS is the only platform purpose-built for life sciences that truly unifies quality compliance, quality assurance, procurement, vendor oversight, and financial spend into a single, integrated system.
Why Unified Matters
Most organizations cobble together disparate systems — a QMS here, procurement software there, financial tools somewhere else. This creates data silos, integration headaches, and manual reconciliation nightmares.
QPOS was architected from the ground up as a unified platform where all five pillars share a common data model, workflow engine, and AI layer. This isn't integration — it's unification.
Single source of truth for all quality, procurement, and financial data
Consistent approval routing, escalation, and delegation across all modules
AI agents work across modules with complete context and traceability
Role-based access control, audit logging, and compliance across platform
Benefits of Unification
- No Integration Burden: No APIs to maintain, no data synchronization, no mapping tables between systems
- Complete Context: Every user sees full context across quality, procurement, and financial dimensions
- Instant Analytics: Cross-functional reporting and analytics without data warehouses or ETL
- Simplified Validation: Single computer system validation instead of multiple integrated systems
- Reduced IT Overhead: One platform to administer, secure, backup, and upgrade
- Better User Experience: Consistent interface, navigation, and workflows across all functions
- Faster Implementation: Deploy once instead of multiple systems with complex integration
Platform Capabilities
- Cloud-Native Architecture: Built for scale, security, and global accessibility
- Mobile-Optimized: Full functionality on tablets and smartphones for field operations
- Offline Capable: Audit execution and data capture work without internet connection
- API-First Design: RESTful APIs for custom integrations with ERP, CTMS, eTMF systems
- Flexible Deployment: SaaS, private cloud, or on-premise options to meet your requirements
- Multi-Tenant Architecture: Support for service providers managing multiple client organizations
- Global Ready: Multi-language, multi-currency, multi-timezone support out of the box
Technology Stack
- Frontend: Modern React-based UI with responsive design and accessibility compliance
- Backend: Microservices architecture with containerization for scalability and resilience
- Database: Enterprise-grade relational database with built-in audit logging and ACID compliance
- AI/ML: Purpose-built machine learning models for quality, procurement, and financial workflows
- Security: SOC 2 Type II, ISO 27001, GDPR compliance with encryption at rest and in transit
- Compliance: 21 CFR Part 11, EU Annex 11, GxP validation packages and documentation
- Infrastructure: Enterprise cloud providers with 99.9% uptime SLA and disaster recovery
Quality & Compliance Solutions
Comprehensive solutions for Quality Assurance, Quality Control, Regulatory Affairs, and Compliance teams — streamlining inspection readiness, CAPA excellence, and continuous compliance monitoring.
For Quality Assurance Teams
- Audit planning and execution with risk-based scheduling
- Finding documentation and CAPA generation workflows
- Root cause analysis with AI-powered suggestions
- Effectiveness verification and closure management
- Trend analysis to identify systemic issues
- Inspection readiness dashboards with evidence compilation
For Quality Control Teams
- Deviation and OOS investigation workflows
- Laboratory data integrity monitoring
- Method validation and equipment qualification tracking
- Environmental monitoring and trending
- Product complaints and adverse event management
- Annual product review (APR) automation
For Regulatory Affairs Teams
- Regulatory intelligence and change tracking
- Gap analysis against new requirements
- Submission preparation and tracking
- Post-approval change management (PACMP)
- Warning letter and 483 observation tracking
- Global harmonization strategy and execution
Key Capabilities for Quality Teams
- Document Control: Centralized SOP management with version control, approval workflows, and training linkage
- Training Management: Automated training assignment, competency tracking, and retraining triggers
- Change Control: Cross-functional change requests with impact analysis and implementation tracking
- Risk Management: Enterprise risk register with FMEA and mitigation tracking
- Supplier Quality: Vendor audit management, CAPA tracking, and performance scorecards
- Inspection Management: Mock inspections, evidence compilation, and response coordination
Procurement & Vendor Management Solutions
End-to-end procurement solutions for Strategic Sourcing, Procurement Operations, and Vendor Management teams — from RFP to contract to ongoing oversight and performance management.
For Strategic Sourcing Teams
- Category spend analysis and market intelligence
- AI-powered vendor discovery and landscape mapping
- RFP/RFI generation with best practice templates
- Proposal evaluation with weighted scoring models
- Total cost of ownership (TCO) analysis
- Strategic sourcing roadmaps and execution tracking
For Procurement Operations
- Purchase requisition to PO automation
- Contract lifecycle management from authoring to renewal
- Supplier qualification workflows with approval routing
- Quality agreement negotiation and tracking
- Change order management and approval
- Procurement compliance and policy enforcement
For Vendor Management Teams
- Vendor scorecards with multi-dimensional KPIs
- Risk-based vendor segmentation and oversight
- Vendor audit planning and execution
- Performance improvement plan tracking
- Vendor relationship management and collaboration
- Supplier diversity program management
Key Capabilities for Procurement Teams
- Spend Visibility: Real-time visibility into spend by category, vendor, project, and business unit
- Vendor Intelligence: AI-powered vendor discovery, due diligence, and performance prediction
- Contract Intelligence: Automated contract analysis, clause extraction, and obligation tracking
- Risk Management: Continuous vendor risk scoring with alerts and mitigation workflows
- Collaboration: Vendor portals for communication, document exchange, and performance feedback
- Integration: Seamless connection to quality systems for supplier quality management
Finance & FP&A Solutions
Comprehensive financial solutions for FP&A, Accounts Payable, Financial Planning, and Budget Management teams — connecting budgets to contracts to invoices with complete reconciliation and variance analysis.
For FP&A Teams
- Multi-level budget planning (portfolio, study, vendor, category)
- Budget modeling and scenario analysis
- Variance analysis with AI-generated explanations
- Forecasting with historical trends and pipeline data
- Executive dashboards and management reporting
- Strategic financial planning integration
For Accounts Payable
- Three-way invoice matching (PO-Receipt-Invoice)
- Exception management and discrepancy resolution
- Payment approval workflows with delegation
- Accrual automation with milestone triggers
- Vendor payment optimization and cash flow management
- Month-end close acceleration with automated reconciliations
For Budget Management
- Contract-linked budget allocation and tracking
- Real-time spend visibility against budgets
- Budget reallocation workflows with approvals
- Change order financial impact analysis
- Budget compliance monitoring and enforcement
- Integration with ERP and financial systems
Key Capabilities for Finance Teams
- Procurement Integration: Budgets linked to contracts, vendors, and quality agreements for complete control
- Automated Reconciliation: AI-powered invoice matching with exception workflows and audit trails
- Variance Intelligence: Automated variance detection with root cause analysis and corrective actions
- Cash Flow Optimization: Smart payment timing based on terms, discounts, and working capital
- Audit Readiness: Complete documentation and audit trail for all financial transactions
- Regulatory Compliance: SOX controls, segregation of duties, and financial governance
Partner Portal
Connect with QPOS to unlock joint opportunities, access partner resources, and collaborate on customer success initiatives.
Partner Benefits
- Deal Registration: Protect your pipeline and earn enhanced margins on registered opportunities
- Co-Marketing: Access marketing development funds and joint campaign resources
- Technical Enablement: Comprehensive training on QPOS platform and solutions
- Partner Certification: Earn recognized credentials to differentiate your expertise
- Opportunity Sharing: Receive qualified leads from QPOS sales team
- Joint Customer Success: Collaborate on implementation and optimization projects
- Partner Advisory Council: Influence product roadmap and partner programs
- Revenue Share: Competitive revenue splits on closed/won deals
Partner Types
- Solution Partners: Implementation, customization, and managed services
- Reseller Partners: Channel sales and customer acquisition
- Technology Partners: Integration development and joint solutions
- Consulting Partners: Strategic advisory and process optimization
- Referral Partners: Lead generation and business development
Partner Portal Features
- Deal Registration System: Submit and track opportunity registrations with approval workflows
- Lead Management: Access qualified leads with CRM integration
- Resource Library: Sales enablement materials, technical documentation, and marketing assets
- Training Academy: Self-paced learning paths with certifications and assessments
- Co-Selling Tools: Collaborate with QPOS sales team on joint opportunities
- Partner Dashboard: Real-time visibility into pipeline, revenue, and certification status
- Support Portal: Technical support for pre-sales and implementation questions
- Community Forum: Connect with other partners to share best practices
Ready to Partner with QPOS?
Join our growing partner ecosystem and help organizations transform their quality, procurement, and financial operations.
Already a Partner?
Access your partner portal to register deals, access resources, and track your performance.
QPOS EW Bridge: APAC ↔ North America Excellence
Industry-leading East-West bridge service enabling seamless operations for sponsors with cross-border clinical trials and quality operations. Our unique dual-region capability ensures native expertise, timezone coverage, and regulatory fluency across both APAC and North America.
Why QPOS EW Bridge is a Game-Changer
Most global sponsors struggle with timezone gaps, cultural differences, and regulatory nuances when operating across APAC and North America. QPOS EW Bridge eliminates these barriers with native teams on both sides, creating a seamless 24/7 quality and operational support framework that feels local everywhere.
Full APAC Coverage
Native teams across key APAC markets
- Japan: Native Japanese-speaking quality and regulatory experts with deep PMDA experience
- China: NMPA-fluent teams for clinical operations and vendor oversight
- South Korea: MFDS regulatory expertise and vendor management
- Australia: TGA compliance and clinical trial support
- India: CDSCO regulatory knowledge and CRO/vendor oversight
- Singapore: HSA expertise and regional hub operations
North America Excellence
Deep FDA/Health Canada expertise
- FDA Fluency: Former FDA inspectors and quality directors on staff
- US Operations: Full support for US-based clinical trials and manufacturing
- Health Canada: Native Canadian regulatory and quality expertise
- Vendor Network: Established relationships with top US CROs, labs, and suppliers
- GxP Expertise: Deep experience across GCP, GMP, and GLP in NA
- 21 CFR Part 11: Comprehensive electronic records and signatures compliance
Seamless Integration
Unified operations across time zones
- 24/7 Coverage: Continuous support across all time zones with native language capabilities
- Daily Handoffs: Structured transition protocols ensure continuity
- Unified Platform: Single QPOS instance with region-specific configurations
- Cultural Bridge: Teams trained in both Western and Asian business practices
- Real-time Collaboration: Integrated communication tools and shared workflows
- Centralized Reporting: Executive dashboards with global and regional views
Key Use Cases for QPOS EW Bridge
NA Sponsors in APAC
Full-service support for North American companies operating in Asia-Pacific
- Regulatory strategy and submissions across APAC health authorities
- Local vendor qualification, auditing, and oversight
- Site management and clinical trial monitoring in APAC
- Quality agreement development with local CROs and suppliers
- Cultural translation and stakeholder management
- Budget and spend reconciliation in local currencies
- CAPA management with local vendors and sites
- Inspection readiness for regional health authority audits
APAC Sponsors in North America
Comprehensive support for Asian companies expanding to US/Canada markets
- FDA/Health Canada regulatory strategy and IND submissions
- US CRO and vendor selection, qualification, and oversight
- Clinical site identification and management in North America
- Quality system setup aligned with FDA expectations
- Pre-approval inspection (PAI) preparation and support
- US-style procurement and vendor governance frameworks
- Financial controls and reconciliation in USD/CAD
- Cultural adaptation and US business practice training
Regulatory Harmonization
Navigate complex multi-region regulatory requirements
- ICH guideline implementation across regions
- Comparative regulatory intelligence (FDA vs. PMDA vs. NMPA)
- Global quality agreement templates with regional addenda
- Harmonized vendor qualification across geographies
- Multi-region inspection readiness
- Cross-border data integrity and ALCOA+ compliance
Vendor Management Excellence
Unified oversight of global vendor networks
- Dual-region vendor scorecards with localized KPIs
- Time-zone optimized vendor audits and oversight
- Cultural competency in vendor communications
- Regional procurement strategies with global visibility
- Multi-currency contract and spend management
- Continuous risk monitoring across vendor portfolio
Operational Excellence
Streamlined cross-border operations
- Follow-the-sun CAPA investigation and closure
- 24/7 document control and change management
- Real-time budget tracking and variance analysis
- Continuous quality monitoring and trending
- Integrated training and competency management
- Unified audit trail across regions
Success Metrics
QPOS Lite - Fractional Services
Flexible, on-demand access to quality, procurement, and compliance expertise without the overhead of full-time hires. Perfect for small biopharma, emerging biotechs, and organizations with variable workload needs.
The Fractional Advantage
Get access to senior-level quality, procurement, and compliance professionals on a part-time, flexible basis. Scale up or down based on your needs — from 10 hours per week to full-time equivalent support — without long-term employment commitments.
Fractional Quality Leadership
Senior QA/QC professionals on flexible schedules
- Fractional QA Director: Strategic quality oversight, inspection readiness, regulatory strategy
- Part-time CAPA Manager: Investigation facilitation, root cause analysis, effectiveness checks
- Document Control Specialist: On-demand SOP development, review, and approval coordination
- Compliance Consultant: Gap analysis, regulatory intelligence, quality system optimization
- Training Coordinator: Curriculum development, GxP training delivery, compliance tracking
- Audit Support: Internal audits, supplier audits, mock inspections
Fractional Procurement & Vendor Management
Expert procurement support without full-time cost
- Fractional Procurement Lead: Vendor selection, negotiation, contract management
- Part-time Vendor Manager: Scorecard management, performance monitoring, relationship oversight
- RFP Specialist: On-demand RFP development, vendor evaluation, selection support
- Contract Analyst: Contract review, amendment processing, compliance monitoring
- Vendor Auditor: Scheduled and ad-hoc vendor qualification audits
- Risk Analyst: Vendor risk assessment, mitigation planning, continuous monitoring
Fractional Finance & Reconciliation
Financial oversight and reconciliation support
- Fractional Finance Manager: Budget oversight, variance analysis, financial reporting
- Part-time Reconciliation Analyst: Monthly reconciliations, exception resolution, accrual processing
- Budget Coordinator: Budget planning, tracking, and forecasting support
- Invoice Specialist: Three-way matching, approval routing, vendor payment coordination
- Financial Analyst: Spend analysis, cost optimization, ROI tracking
- Month-end Support: Surge support for financial close activities
Flexible Engagement Models
Time-based Packages
- 10 Hours/Week: Light-touch oversight and strategic guidance
- 20 Hours/Week: Regular operational support and project work
- 30 Hours/Week: Substantial engagement with consistent presence
- 40 Hours/Week: FTE-equivalent coverage with dedicated resource
- Custom Schedules: Tailored to your specific needs and peak periods
- Surge Support: Ramp up for inspections, audits, or critical periods
Project-based Engagements
- Inspection Preparation: 4-8 week intensive readiness project
- QMS Implementation: 12-16 week system deployment support
- Vendor RFP: 6-10 week vendor selection project
- CAPA Backlog Clearance: 8-12 week investigation and closure sprint
- Document Migration: 4-8 week legacy system migration
- Audit Response: 2-4 week finding remediation support
When to Choose QPOS Lite
✅ Ideal For:
- → Early-stage biotech with limited budgets
- → Virtual organizations without fixed office space
- → Pre-revenue companies preparing for inspections
- → Organizations with variable workload (study-dependent)
- → Companies between FTE hires needing coverage
- → Temporary capacity for special projects or audits
💰 Cost Advantages:
- → 40-60% lower cost than full-time equivalent
- → No benefits, payroll taxes, or overhead costs
- → Flexible scaling without HR complexity
- → Access to senior expertise at fractional cost
- → Pay only for time used, no idle capacity
- → Predictable monthly costs with usage transparency
QPOS FSP - Dedicated Resourcing
Functional Service Provider model delivering dedicated, embedded teams for quality, procurement, vendor management, and financial operations. Your extended team with deep platform expertise and continuous operational support.
FSP: Your Embedded Quality & Operations Team
Unlike fractional services, our FSP model provides dedicated, long-term teams that become an extension of your organization. These professionals work exclusively on your operations, master your processes, and deliver consistent, high-quality outcomes with deep institutional knowledge.
Dedicated Quality Operations Team
Full-service quality team embedded in your organization
- QA Manager: Your dedicated quality lead overseeing all GxP operations
- Document Controllers: Full-time SOP management, revisions, and approval coordination
- CAPA Specialists: Investigation execution, root cause analysis, closure verification
- Training Coordinators: Curriculum delivery, compliance tracking, retraining management
- Audit Coordinators: Internal audit execution, finding tracking, CAPA response
- Quality Analysts: Metrics tracking, trending analysis, continuous improvement
Dedicated Procurement & Vendor Team
End-to-end procurement and vendor oversight
- Procurement Manager: Strategic sourcing, vendor strategy, procurement operations
- Vendor Coordinators: Qualification, onboarding, relationship management
- Contract Specialists: Agreement negotiation, lifecycle management, compliance
- RFP Analysts: RFP development, evaluation, vendor selection support
- Vendor Auditors: Scheduled audits, quality assessments, risk monitoring
- Performance Analysts: Scorecard maintenance, KPI tracking, trend reporting
Dedicated Finance & Reconciliation Team
Continuous financial operations and reconciliation
- Finance Manager: Budget oversight, financial reporting, variance analysis
- Reconciliation Analysts: Daily PO-Receipt-Invoice matching and exception resolution
- Accounts Payable Specialists: Invoice processing, payment coordination, vendor inquiries
- Budget Analysts: Forecasting, tracking, variance investigation
- Accrual Coordinators: Month-end accrual processing and reversals
- Financial Reporters: Dashboard management, executive reporting, analytics
FSP Service Levels & Team Configurations
Small Team (3-5 FTEs)
Perfect for small biopharma and emerging biotechs
- 1 QA Manager + 2 Quality Specialists
- Or: 1 Procurement Lead + 1 Vendor Coordinator + 1 Finance Analyst
- Single-region support (NA or APAC)
- Business hours coverage (8x5)
- Dedicated Slack/Teams channel
- Weekly status meetings
- Monthly performance reporting
Medium Team (6-12 FTEs)
For growing organizations with multiple studies
- Cross-functional team (Quality + Procurement + Finance)
- 2 Managers + 4-10 Specialists/Analysts
- Multi-region support available
- Extended hours coverage (12x6)
- Integrated collaboration platform
- Bi-weekly leadership syncs
- Real-time dashboards and reporting
Large Team (13-30+ FTEs)
Enterprise-scale FSP deployment for mid-large pharma
- Fully integrated Quality, Procurement, Vendor, and Finance operations
- 3-5 Managers + 10-25+ Specialists across all functions
- Global coverage with QPOS EW Bridge (APAC ↔ NA)
- 24/7 follow-the-sun support model
- Dedicated executive account management
- Weekly leadership reviews and monthly business reviews
- Custom SLAs and performance guarantees
- Integration with your enterprise systems (SAP, Oracle, Veeva)
Key FSP Advantages
- Institutional Knowledge: Dedicated team learns your processes, culture, and systems
- Consistency: Same people every day, no resource churn or knowledge loss
- Scalability: Easily add or reduce team members as needs evolve
- Cost Efficiency: 30-50% lower than equivalent FTE hires
- No Recruiting: We handle hiring, training, and retention
- Rapid Deployment: Team up and running in 2-4 weeks
Platform Integration
- QPOS Experts: Team trained on Q²POS platform from day one
- Best Practices: Leverage cross-customer learnings and optimizations
- System Configuration: Optimize workflows for your specific needs
- Continuous Improvement: Regular process refinements and efficiency gains
- Your Systems: Can also work with your existing QMS, ERP, procurement tools
- Hybrid Model: Seamless integration of QPOS + your legacy systems
Service Level Commitments
- Response Times: Guaranteed SLAs for issue escalation and resolution
- Quality Metrics: CAPA closure rates, audit finding timelines, training compliance
- Vendor Performance: Scorecard accuracy, audit completion rates, risk detection
- Financial Accuracy: Reconciliation error rates, month-end close timelines
- Uptime Guarantee: 99.5% availability commitment with backup coverage
- Performance Reviews: Quarterly reviews with continuous optimization
FSP vs. Traditional Hiring
⚡ Faster Deployment
2-4 weeks vs. 3-6 months for traditional hiring
💰 Lower Cost
30-50% savings vs. FTE total compensation
🔄 Flexibility
Scale up/down without HR complexity or severance
🎯 No Turnover Risk
We manage retention and provide backup coverage
QPOS Academy - Professional Certifications
Industry-leading certification programs for quality professionals, procurement specialists, clinical research professionals, and quality system administrators. Master the QPOS platform and advance your career in life sciences quality and compliance.
Certifications That Advance Careers
QPOS Academy certifications are modeled after industry standards like Medidata Rave Certification and Veeva Vault Certification. Our programs validate platform expertise and domain knowledge, creating career advancement opportunities for quality professionals, CRAs pivoting to QA/procurement, and site staff moving into sponsor-side roles.
🎓 QPOS Quality Professional Certification
Core certification for QA/QC professionals using QPOS
- Level 1 - User: Document control, training management, basic CAPA workflows (8 hours)
- Level 2 - Power User: Advanced CAPA, audit management, change control (16 hours)
- Level 3 - Administrator: System configuration, workflow design, user management (24 hours)
- Prerequisites: Basic GxP knowledge, familiarity with quality systems
- Exam: Online proctored exam (90 minutes, 80% passing score)
- Renewal: Annual recertification with continuing education credits
📦 QPOS Procurement Specialist Certification
For procurement and vendor management professionals
- Level 1 - User: Vendor onboarding, RFP basics, contract management (8 hours)
- Level 2 - Power User: Advanced RFP, vendor scorecards, risk management (16 hours)
- Level 3 - Administrator: System setup, vendor workflows, integration configuration (24 hours)
- Prerequisites: Procurement experience or equivalent training
- Exam: Online proctored exam (90 minutes, 80% passing score)
- Renewal: Annual recertification with continuing education
💰 QPOS Financial Analyst Certification
Budget tracking, reconciliation, and spend management
- Level 1 - User: Budget basics, invoice matching, basic reconciliation (8 hours)
- Level 2 - Power User: Advanced reconciliation, variance analysis, accruals (16 hours)
- Level 3 - Administrator: Financial setup, ERP integration, reporting configuration (24 hours)
- Prerequisites: Basic accounting knowledge or finance experience
- Exam: Online proctored exam (90 minutes, 80% passing score)
- Renewal: Annual recertification with continuing education
🔄 Career Transition Programs
Special certification tracks designed for clinical research professionals looking to pivot into quality, procurement, or vendor governance roles. These programs combine platform training with domain expertise to enable successful career transitions.
CRA → Quality Assurance Track
For CRAs and site coordinators transitioning to sponsor-side QA
- Module 1: GCP to GMP transition - regulatory frameworks
- Module 2: Quality systems fundamentals (QMS, CAPA, audits)
- Module 3: QPOS Quality platform training and certification
- Module 4: Sponsor-side audit execution and finding management
- Module 5: Inspection readiness and regulatory interactions
- Duration: 12 weeks (part-time) or 6 weeks (full-time)
- Certification: QPOS Quality Professional Level 2
Site Staff → Procurement Track
For site coordinators and PMs moving into procurement/vendor governance
- Module 1: Procurement fundamentals for life sciences
- Module 2: Vendor selection, qualification, and oversight
- Module 3: QPOS Procurement platform training and certification
- Module 4: Contract negotiation and lifecycle management
- Module 5: Vendor risk management and scorecards
- Duration: 10 weeks (part-time) or 5 weeks (full-time)
- Certification: QPOS Procurement Specialist Level 2
PM/Project Support → Vendor Governance Track
For project managers transitioning to vendor oversight roles
- Module 1: Vendor governance frameworks in clinical research
- Module 2: Risk-based vendor oversight and monitoring
- Module 3: QPOS Oversight platform training
- Module 4: Vendor performance management and scorecards
- Module 5: Change control and governance workflows
- Duration: 8 weeks (part-time) or 4 weeks (full-time)
- Certification: QPOS Oversight Specialist Level 2
Finance/Admin → Spend Reconciliation Track
For administrative and finance staff moving into clinical spend management
- Module 1: Clinical trial budget structures and milestones
- Module 2: Three-way matching and reconciliation fundamentals
- Module 3: QPOS Financial platform training
- Module 4: Variance analysis and accrual processing
- Module 5: Month-end close and financial reporting
- Duration: 8 weeks (part-time) or 4 weeks (full-time)
- Certification: QPOS Financial Analyst Level 2
Learning Formats
- Self-paced Online: Video modules, interactive labs, knowledge checks
- Live Virtual Classes: Instructor-led training with Q&A sessions
- In-person Bootcamps: Intensive 3-5 day immersive training (select locations)
- Blended Learning: Combination of self-paced and live instruction
- Corporate Training: Customized programs delivered on-site for teams
- Hands-on Labs: Sandbox environment for practical exercises
Career Benefits
- Industry Recognition: Validated credential from leading platform provider
- Resume Enhancement: Demonstrate platform expertise to employers
- Salary Increase: Certified professionals command 15-25% premium
- Career Mobility: Transition between CRO, site, and sponsor roles
- Job Board Access: Exclusive access to QPOS-enabled organizations hiring
- Continuing Education: Free access to advanced topics and updates
Certification Process
- Step 1: Enroll in certification track and complete prerequisites
- Step 2: Complete required training modules and hands-on labs
- Step 3: Pass online proctored examination (80% minimum)
- Step 4: Receive digital badge and certificate
- Step 5: Maintain certification through annual renewal
- Recertification: 10 continuing education credits per year