ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...
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 ...
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) This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers ...
Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Risk-based Computer System Validation; Reduce Costs and Avoid 483s (ONLINE EVENT: August 6-7, 2025)" has been added to ResearchAndMarkets.com's offering.
This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP®5. Computerised ...
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. 18, 2025 (GLOBE NEWSWIRE) -- The "Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities (Oct 16th - Oct 17th, 2025)" training has ...
(MENAFN- GlobeNewsWire - Nasdaq) Join this interactive two-day course to master cost-effective computer system validation. Learn the 10-step risk-based approach to cut compliance costs by two-thirds ...