Quality Management Documents & Templates
FDA 21 CFR 820 Quality System Regulation Compliance Checklist •
Are you using a protocol for this validation (defined operating conditions)?
Are you using initial production units, lots, or batches?
Are units tested under simulated use conditions?
Was software validation included?
Was Hazard (Risk) Analysis performed?
Is this process documented in the DHF? 5.11
Is there a procedure that controls/ensures device design is correctly translated into production specifications?
Is there a formal process to ensure this transfer (such as development report or product transfer team)?
Design Changes Are there procedures ensuring identification documentation validation, verification, review and approval of design changes before their implementation? 5.12
Design History File
Do you have a Design History File for each type of device? Does the file contain: Design review minutes Design verification and validation protocols and reports Design transfer documentation
Customer Comments on Section: 820.30
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