Maintained for the entire record retention period. Available: Accessible for review during inspections. Regulatory Frameworks Compliance is non-negotiable and governed by global bodies: FDA 21 CFR Part 11: Electronic records and signatures. EU GMP Annex 11: Computerized systems requirements. MHRA GXP: Guidance on data integrity expectations. ISO 13485: Quality management for medical devices. High-Risk Areas Data breaches often occur in these specific stages:
"Testing into compliance" or deleting failed results. Data Integrity in Pharmaceutical and Medical De...
Build a "No-Blame" environment to encourage error reporting. Maintained for the entire record retention period
Transcription errors or backdating in logbooks. Legacy Systems: Old software lacking modern audit trails. Data Integrity in Pharmaceutical and Medical De...