FDA 21 CFR 820: Quality System Regulation
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21 CFR 820, the Quality System Regulation, sets forth the current good manufacturing practice (cGMP) requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. This part establishes basic requirements applicable to manufacturers of finished medical devices.
Sections commonly cited in software deficiencies include:
- 820.30 Design Controls
- 820.40 Document Controls
- 820.50 Purchasing Controls
- 820.70(b) Productions and Process Changes
- 820.70(i) Automated Processes
- 820.75 Process Validation
- 820.100 Corrective and Preventive Action
- 820.198 Complaint Files
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