GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device QSIT Manual with 11, 803, 806, 820 and 821

10Part11.803.806.820.821.jpg
978-1-935131-10-6

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 803 - Medical Device Reporting
Part 806 - Medical Devices; Reports of Corrections & Removals
Part 820 - Quality Systems Regulations
Part 821 - Medical Device Tracking Requirements

Quality System Inspection Technique (QSIT) - Guide to Inspections of Quality Systems August 1999




















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