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FDA 21 CFR Part 820 quality system regulations exist to make plain the Current Good Manufacturing Practice (CGMP) guidelines that . Download Free Resources . Q&A: Compliance with 21 CFR 820 and ISO 13485 Using MasterControl.. Subpart A - General Provisions ( 820.1 - 820.5) Subpart B - Quality System Requirements ( 820.20 - 820.25) Subpart C - Design Controls ( 820.30).. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER.. Quality Management Software Exclusively for Medical Device Companies. FDA QSR (21 CFR PART 820). ISO 13485:2016. 1 Scope. 2 Normative References.. 21CFR Part 820. Current good manufacturing practice. (CGMP) requirements are set forth in this quality system regulation. Basis for GMP Revision. f549106f9e
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