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.
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
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 ...
The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...
DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...
Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "IQ, OQ, PQ in the Verification and Validation Process (Jan 28, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will ...
The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
Validfor is excited to announce the launch of its Agentic Digital Validation Platform for life sciences, designed to ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
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