CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "FDA's 21 CFR Part 11 Add-on Inspections (Jan 12, 2026)" training has been added to ResearchAndMarkets.com's offering. The verification and validation of ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.
Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes ...
InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
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