Simplifying Part 11
In August 1997, three major events that happened include: 1) Apple and Microsoft announced a partnership, 2) the Teamsters Union strikes related to issues surrounding pensions and part-time workers and 3) 21 CFR Part 11 becomes effective. Personally, I had no idea about those first two national events, but 1997 was my first year in […]
A Q&A: The Trials and Triumphs of CSV
This article also appears on MasterControl’s GxP Lifeline. Computer system validation (CSV) can be a painful topic. That’s understandable, considering how much work goes into traditional CSV. Months of time are dedicated to the process, which produces piles of documentation. For companies working in industries regulated by the U.S. Food and Drug Administration (FDA), the agency’s intentionally […]