Digital CMC Summit Event Brief The 1st Annual Digital CMC Summit brought together more than 20 expert industry speakers presenting to an engaged audience representing …
Do or Do Not… There is No Try in Digital Transformation Read More »
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 …
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 …
FDA Shares Insights on Digital Transformation & Manufacturing Modernization Read More »
Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting On August 22, 2019, I was invited by the IoPP – Puerto …
What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »
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 …
FDA Answers Your Questions on the New Approach to CSV Read More »
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 …
eBook: CSA – A Streamlined Approach to Validation Read More »
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 …
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 …
