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 […]
Presented by: Era Sciences As regulatory scrutiny around computerized systems continues to grow, staying inspection-ready is no longer optional. In this webinar, we’ll explore how life sciences teams are enhancing oversight, validation, and audit preparedness across both GxP and GCP environments. You’ll learn why maintaining a reliable, compliant, and up-to-date asset list of computerized systems […]
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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