Test Method Validation, Measurement Systems, and Gauge R&R


When the U.S. Food and Drug Administration (FDA) issued The Guidance on Test Method Validation, they failed to address the validation of measurement systems – but 21 CFR Part 820 requires measurement system analysis (MSA). To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation. Now what? Read the full article written by Coda Corp USA.



2020-bl-author-gina-guideo-redden

Gina Guido-Redden is a quality and regulatory professional with over 25 years of domestic and international industry experience. She is the co-founder and chief operations officer of Coda Corp USA, which provides consultancy services to pharmaceutical, biologics and medical device firms.

Guido-Redden’s history specializes in the areas of facility start up, regulatory compliance and remediation, quality system development, mentorship and training, quality system design, and implementation and management.

She is also a quality systems subject matter expert (SME), frequent seminar presenter, and content contributor to industry publications, including GAMP’s White Paper on Part 11, The Journal of Validation Technology, New Generation Pharmaceuticals, Computer Validation Digest, and MasterControl’s GxP Lifeline. Coda Corp USA is an enterprise partner of MasterControl.


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