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Monitor key compliance areas for regulatory inspection preparedness
SOPs current, training records up-to-date, batch records complete
Qualification matrix, GMP training, competency assessments
Instrument calibration, method validation, stability program
Equipment qualification, preventive maintenance, cleaning validation
Audit trails, access controls, backup/recovery procedures
Change control, CAPA, deviation management, OOS investigations
Pre-built checklists based on regulatory frameworks (Coming Soon)
FDA 21 CFR Part 211: GMP Compliance Audit (Manufacturing, QC, QA, Facilities)
FDA 21 CFR Part 11: Electronic Records & Signatures, Computerized Systems
EU GMP Annex 11: Computerised Systems Validation & Data Integrity
ICH Q10: Pharmaceutical Quality System, Management Responsibility, CAPA
PIC/S Guide: Good Manufacturing Practices, GDP
Comprehensive overview of all audits and inspections
Detailed analysis of findings by type, category, and status
CAPA implementation and effectiveness metrics
Audit and finding trends over time