FDA Releases New Draft Guidance on CSA
Computer Software Assurance for Production and Quality System Software The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a …
CSA
FDA Shares Insights on Digital Transformation & Manufacturing Modernization
The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The …
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What to Expect in FDA’s Draft Guidance on Computer Software Assurance
Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting On August 22, 2019, I was invited by the IoPP – Puerto …
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FDA Answers Your Questions on the New Approach to CSV
Q&A from an Axendia Straight from the Source (SftS) Webinar By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President In our recent webinar, we …
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eBook: CSA – A Streamlined Approach to Validation
Computer System Assurance in Support of Manufacturing 4.0 By: Daniel R. Matlis, President Computer System Validation (CSA) is a streamlined approach to validation that supports …
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FDA Shares a New Approach to CSV
A Straight from the Source Webinar The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to …
At 21, Computer System Validation Comes of Age
Stop Validating Computer Systems to Death! By: Daniel R. Matlis, President “FDA emphasizes that manufacturers are responsible for the adequacy of the software used in …