Tag Archives: Quality System Record

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

Quality System Record

By Dr. Christopher Joseph Devine
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…

Continue reading