Electronic Records & Signatures
FDA 21 CFR Part 11
QA Stack guarantees data integrity for all electronic records and signatures. Every critical action requires re-authentication, capturing the user's identity, the exact server-verified timestamp, and the semantic meaning of the signature.
- Immutable, time-stamped system audit trails.
- Forced password re-authentication for approvals.
- Strict role-based access controls (RBAC).
AUDIT TRAIL PREVIEW
European Regulations
ANNEX 11 COMPLIANCE
- Validation Documentation
- Periodic Evaluation
- Data Storage & Archiving
- Business Continuity
- Incident Management
EU GMP Annex 11
Fully compliant with the European Medicines Agency (EMA) guidelines for computerized systems. QA Stack provides complete transparency into system architecture, data storage, and IT disaster recovery procedures.
- Comprehensive disaster recovery & backup systems.
- Automated incident and IT deviation management.
- Clear segregation of duties.
Risk-Based Validation
ISPE GAMP® 5
We embrace the ISPE GAMP 5 risk-based approach to compliant GxP computerized systems. As a Category 4 (Configured Software) product, QA Stack significantly reduces your validation burden by providing executed IQ/OQ packages.
- Pre-executed Installation & Operational Qualification (IQ/OQ).
- Risk-based Performance Qualification (PQ) templates.
- Change management for platform updates.
V-MODEL TRACEABILITY
Pharmaceutical Quality Systems
ICH Q10
QA Stack natively embodies the ICH Q10 Pharmaceutical Quality System model. By connecting process performance, product quality monitoring, CAPA, and Change Management into a single data layer, management review becomes continuous rather than periodic.
ISO 9001
Designed to support continuous improvement methodologies. The platform ensures strict adherence to documented information control, resource management, and risk-based decision making required for ISO 9001 certification.