The U.S. Food and Drug Administration has just made it official: your excuses for clinging to outdated systems because of antiquated validation practices are gone. […]
FDA CSA Just Removed Your Excuses for Implementing Modern Technology Read More »
Experts from IBM and Axendia shared the Journey to CSA in “Welcome to Wednesday” Maximo Event. FDA’s Computer Software Assurance (CSA) draft guidance is intended
Journey from Computer Software Validation (CSV) to Computer Software Assurance (CSA) Read More »
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 »
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What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »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
FDA Shares a New Approach to CSV Read More »
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
At 21, Computer System Validation Comes of Age Read More »
