Recordkeeping and document retention
Recordkeeping and document retention in Healthcare & Life Sciences sits under active enforcement pressure from the U.S. Department of Health and Human Services Office for Civil Rights, the U.S. Food and Drug Administration, and the European Medicines Agency, each operating distinct retention schedules, audit trail requirements, and destruction protocols that do not align with one another. FDA's 21 CFR Part 11 requirements for electronic records remain a live audit trigger, and HHS OCR has continued to cite inadequate retention controls in HIPAA enforcement actions. Compliance teams managing multi-jurisdictional operations are reconciling these obligations now, not waiting for the next audit cycle.
Watch
- FDA 21 CFR Part 11 audit trail gaps cited in recent device and pharma inspections
- HHS OCR HIPAA enforcement pattern: retention failures tied to breach investigations
- EMA Annex 11 computerised systems guidance and its document lifecycle expectations
- State-level retention divergence: California CMIA adds requirements beyond federal HIPAA floor
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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