Increasing adoption of CSV in regulated industries is a key factor propelling growth of the global computer system validation market. The use of computer systems can automate, accelerate and improve ...
Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational ...
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 ...
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.
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 ...
The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized ...
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 ...
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC. Q. I just started working for an ...