Tag Archives: Quality System Record

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Quality System Record

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.186 (Quality System Record). The Quality System Record, not to be confused with the Quality System Regulation, can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. The key for compiling a QSR and ongoing compliance with the QSR (y…

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