QiXPharm
Pharmaceutical AI Governance Framework
GxP-ready pharmaceutical governance with Computer Systems Assurance (CSA) compliance, ALCOA+ data integrity, batch release controls, and cold chain monitoring for regulated manufacturing environments.
ALCOA+ Ready
Complete ALCOA+ data integrity framework ensuring Attributable, Legible, Contemporaneous, Original, Accurate data management.
GxP Compliance
Full Good Practice guidelines compliance including GMP, GLP, and GCP for pharmaceutical and life sciences operations.
CSA Validation
Computer Systems Assurance methodology with risk-based validation from scripted to unscripted testing continuum.
Cold Chain Monitoring
Real-time temperature tracking with excursion detection, automated alerts, and comprehensive audit trails for product integrity.
Regulatory Compliance Coverage
QiXPharm provides comprehensive compliance with global pharmaceutical regulations and standards.
FDA 21 CFR Part 11
Complete electronic records and electronic signatures compliance for US FDA regulated environments.
- Electronic signature workflows
- Audit trail generation
- System validation protocols
- Access control and authentication
EU Annex 11
European Medicines Agency computerized systems requirements for pharmaceutical manufacturing.
- Risk management framework
- Supplier management
- Validation lifecycle
- Data integrity controls
WHO GMP
World Health Organization Good Manufacturing Practice guidelines for pharmaceutical products.
- Quality management systems
- Documentation requirements
- Manufacturing controls
- Product quality review
MHRA GxP
UK Medicines and Healthcare products Regulatory Agency data integrity guidelines.
- Data governance framework
- ALCOA+ principles
- Data lifecycle management
- Audit trail requirements
Enterprise Use Cases
QiXPharm addresses critical pharmaceutical manufacturing and compliance scenarios.
MES Upgrades
Govern AI-assisted Manufacturing Execution System upgrades with risk-based validation, change management workflows, and automated evidence generation for regulatory submissions.
LIMS Validation
Automate Laboratory Information Management System validation with CSA methodology, reducing validation cycle time while maintaining full regulatory compliance and audit readiness.
Cold Chain Monitoring
Real-time AI-powered temperature monitoring with predictive excursion detection, automated alerts, and complete audit trails for product integrity assurance across the supply chain.
Batch Release
AI-assisted batch release decisions with multi-model consensus, automated quality review, and cryptographically signed evidence bundles for regulatory approval and traceability.
Technical Architecture
Built on IOA Core with pharmaceutical-specific extensions and integrations.
Application Layer
Governance Layer
Compliance Layer
IOA Core
Deploy QiXPharm in Your Organization
Get production-ready pharmaceutical AI governance with CSA compliance, ALCOA+ data integrity, and multi-jurisdiction regulatory support. Request a demo to see QiXPharm in action.