AI | Article | Data Integrity | GMP | White Paper
Ronald D. Snee, PhDSnee Associates, LLC In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.” Metadata is also of concern when assessing […]
AI | Article | Data Integrity | GMP | White Paper
Published By VTI Life Sciences Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must […]
Reshma Kodumuru, Principal CSV, KBI BioPharma Abstract With the rapid rate of digital change nowadays, ensuring data is secure and intact across complicated systems is the biggest challenge for the pharmaceutical industry. Government agencies such as the FDA, EMA, MHRA, and ICH all emphasize that trustworthy data, being complete, consistent, and accurate, is the foundation […]
Taylor DieringerSenior Staff Quality Engineer – Risk Management iRhythm Technologies, Inc. In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance. A clear, intentional structure supports traceability, aligns with ISO 14971:2019, and enables effective risk control. This article explores three common structures for hazard analysis and […]
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