As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and ...
DUBLIN, Nov. 21, 2023 /PRNewswire/ -- The "3-Hour Virtual Seminar on Computer System Validation (CSV) vs. Computer Software Assurance (CSA) - Following a Waterfall vs. Agile Methodology" webinar has ...
The main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative technologies like AI, ML, and ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution ...
DUBLIN--(BUSINESS WIRE)--The "The FDA Recently Released a New Draft Guidance Related to Part 11" webinar has been added to ResearchAndMarkets.com's offering. As part of the Case for Quality program US ...
Blood Assurance partners with BBCS to implement ForLife Biologics PlatformTM, streamlining operations & enhancing donor experiences. BONNEY LAKE, WA, UNITED STATES, September 2, 2025 /EINPresswire / - ...
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