Aug. 20 at 2:20 PM
$BSEM Part 1: A crucial part of the inspection is the review of various documents, including:
Quality System Documentation: This includes the quality policy, management representative, deviation reports, management review records, internal audit reports, quality plans, and CAPA (Corrective and Preventive Action) procedures.
Device History Records (DHR): These records document the entire production history of a specific device, including dates, times, personnel involved, and processes followed.
Standard Operating Procedures (SOPs): These are detailed instructions for how various manufacturing processes should be performed, and the FDA will compare these to the DHRs.
Non-Conformance and CAPA Reports: These reports detail any deviations from standard procedures and the actions taken to correct them.
Validation and Verification Reports: These reports demonstrate that the manufacturing processes consistently produce devices that meet specifications.
