FDA electronic records, device quality systems, and design controls documentation.
FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures used in place of paper records in FDA-regulated environments — covering pharmaceutical, medical device, biologics, and food manufacturing. Part 11 compliance requires validated computer systems, complete audit trails, and controlled electronic signature documentation.
21 CFR Part 820 (Quality System Regulation) governs the design and manufacturing of medical devices, requiring documented quality management systems covering design controls, document control, complaint handling, corrective and preventive action (CAPA), and production processes. FDA investigations frequently focus on whether a firm's documentation systems demonstrate that its quality system was followed — making documentation architecture a direct regulatory defense mechanism.
Design and development documentation: inputs, outputs, reviews, verification, validation, and transfer records.
Document approval, distribution, obsolete document control, and change control procedures.
Supplier qualification documentation, purchase specifications, and supplier evaluation records.
Process documentation, process validation protocols, and production record requirements.
Corrective and preventive action documentation, root cause analysis records, and effectiveness verification.
Quality records control, retention periods, and FDA access requirements.
Templates and implementation resources for FDA 21 CFR Part 11 & 820 are available through the ELDR Institute Knowledge Hub and via direct request.