Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements Course" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...
The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...
TEKLYNX label security and traceability software, plus validation accelerator pack, streamlines label approval and audit readiness for medical device manufacturer AUCH, France, May 25, 2022 ...
Syngene, a world-leading manufacturer of image analysis solutions, has announced that it has produced new software and validation information for its Dyversity, G:BOX and GeneGnome range of image ...
Syngene has announced that it has produced new software and validation information for its Dyversity, G:BOX and GeneGnome range of image analysis systems. This makes them ideal for scientists in ...
(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning ...
(MENAFN- GlobeNewsWire - Nasdaq) FDA Warning Letters highlight critical cGMP deficiencies in V&V planning. Discover how to optimize Master Validation Plan elements against ISO 14971 for effective ...