📋 21 CFR Part 11

21 CFR Part 11 & GxP Compliance

Electronic records, electronic signatures and Good Practice (GxP) compliance for clinical research and regulated systems

💻 Regulated System Inventory
All GxP systems subject to 21 CFR Part 11 electronic records and signature requirements
System Name System Type Validation Status Last Validation Audit Trail E-Sig Compliant Risk Level Actions
4/5 systems validated (80%)
LabWare LIMS validation in progress — target completion Q3 2026
80%
✅ 21 CFR Part 11 Compliance Checklist
Track compliance against core Part 11 regulatory requirements — click items to toggle
Electronic Records (11.10)
Electronic Signatures (11.100 / 11.200)
15/19 requirements met (79%) Partial Compliance Last updated: today
🔬 Computer System Validation Projects
IQ / OQ / PQ validation lifecycle tracking — click phase cells to view checklist
System Phase IQ OQ PQ Validation Report Status Due Date
🔍 Periodic Audit Trail Review

FDA guidance requires periodic review of audit trails for GxP systems. Critical systems: monthly. Others: quarterly.

System Review Frequency Last Review Next Due Reviewer Status
🤖 AI Audit Trail Analysis
Upload audit trail export for AI-assisted anomaly detection and data integrity review
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🤖 AI Anomaly Analysis Results
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