GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device QSIT Manual with 11 and 820

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978-1-935131-18-2

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 820 - Quality Systems Regulations

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

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