Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" training has been added to ResearchAndMarkets.com's offering. Upon ...
Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be ...
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic ...
Dublin, Sept. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The ...
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 ...
InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...
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 ...
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 ...
Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...
The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized validation approaches. This webinar explores digital computer system validation ...
"You are only as strong as your weakest link." I cannot think of a better proverb when it comes to surviving in an industry as regulated and as nerve-wracking as pharmaceuticals or life sciences. One ...