Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...

Dublin, Jan. 17, 2024 (GLOBE NEWSWIRE) -- The "FDA Compliance and Clinical Trial Computer System Validation Course" training has been added to ResearchAndMarkets.com's offering. The FDA governs the ...

Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" training has been added to ResearchAndMarkets.com's offering.

DUBLIN--(BUSINESS WIRE)--The "CSV Boot Camp - 3-Day Certification Course" training has been added to ResearchAndMarkets.com's offering. This seminar is intended for those involved in planning, ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a prominent Brazilian government entity, a ...