Compliance & Security
FDA 21 CFR Part 11, EU Annex 11, and GxP compliance management
21 CFR Part 11
FDA
Electronic Signatures
All signatures include full name, date/time, and meaning
Audit Trail
Complete, unalterable audit trail with timestamps
Access Controls
Role-based access with MFA enforced
Data Integrity
Checksums verified, no unauthorized modifications
System Validation
IQ/OQ/PQ documentation due for annual review (14 days)
Record Retention
Records retained per 21 CFR 11.10(c) requirements
EU Annex 11
EMA
Risk Management
Risk assessment documented per Annex 11 §1
Validation
Life cycle approach with documented evidence
Data Storage
Periodic backup integrity checks passing
Printouts
Electronic records can generate complete printouts
Business Continuity
DR test scheduled — last completed 87 days ago
Electronic Signatures
Permanently linked to respective records
GxP Compliance
Global
GLP — Laboratory
Good Laboratory Practice controls verified
GCP — Clinical
Good Clinical Practice data integrity confirmed
GMP — Manufacturing
Manufacturing data controls in compliance
GVP — Pharmacovigilance
Module VI signal management controls active
GDP — Distribution
Distribution data tracking validated
ALCOA+ Principles
Attributable, Legible, Contemporaneous, Original, Accurate