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 ...
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 ...
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems. Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for ...
Dublin, Nov. 07, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ...
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 ...
In today's fast-moving world of vaccines, gene therapies and biotherapeutics, computerized systems play a critical role in the discovery, manufacture and delivery of potentially life-saving drugs.
(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback