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Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist 978-1-935131-08-3 US FDA Title 21 CFR Parts Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals 21 CFR Part 820 - Quality Systems Regulations QSR Audit Checklist Medical Device Quality Systems Manual Quality System Regulation Auditor's Self Assessment Check List For persons who purchased this item, you may also be interested in: GMP Auditor’s Basic Handbook

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