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, ...

(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 ...

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You’ll learn about what processes needed to be ...

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

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 ...

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 ...