An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel. Q. We recently performed a detailed ...

Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational ...

The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized ...

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) (Nov 4th - Nov 6th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in technology have ...

Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...

If new digital capabilities and top-notch data are critical to process efficiency and competitive advantage, it makes no sense to leave validation (proof that they fulfil what’s required) until the ...