FDA 21 CFR Part 11 Part11.RecordRetention: Record protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

Section 11.10(b) + (c) record protection + retention + inspection requirements: (b) THE ABILITY TO GENERATE ACCURATE AND COMPLETE COPIES OF RECORDS IN BOTH HUMAN READABLE AND ELECTRONIC FORM SUITABLE FOR INSPECTION + REVIEW + AND COPYING BY THE AGENCY - records must be exportable in both human-readable (PDF + print) + electronic (XML + JSON + CSV + native format) forms; copies must be ACCURATE (faithful to original) + COMPLETE (no omissions or summarisation); FDA inspectors expect to receive copies on request typically within minutes for routine inspection + hours for complex queries. (c) PROTECTION OF RECORDS TO ENABLE THEIR ACCURATE AND READY RETRIEVAL THROUGHOUT THE RECORDS RETENTION PERIOD - retention periods derive from underlying agency-regulation requirements (typically 2 years post-clinical-trial-close for clinical; 5+ years for medical-device QMSR records; longer for biologics + manufacturing batch records); records must be: (i) protected against accidental + deliberate alteration + destruction during the retention period; (ii) accessible + retrievable throughout the retention period including across system migrations + obsolescence; (iii) backed up with disaster recovery; (iv) destroyed only after retention period elapses + with documented authorisation. Part 11 record retention coordinates with HIPAA + state record-retention rules + the FDA Bioresearch Monitoring (BIMO) inspection scope.