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 […]
Presented by: Rene Marcotte, Life Sciences, Senior Vice President, Delivery and Practice Management, RCM Technologies Artificial Intelligence (AI) has rapidly evolved from potential to reality. As organizations seek to leverage AI for process optimization and competitive advantage, the importance of data quality and governance has become paramount. AI’s ability to learn and make accurate decisions […]
This forward-looking discussion dives into how AI is transforming validation workflows in the medical device space. Discover how companies are using machine learning and automation to drive speed, accuracy, and regulatory compliance—all without compromising quality. Tune in for actionable insights that will prepare you to integrate digital solutions into your validation process. What You’ll Gain: […]
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 […]
Presented By: Steve Thompson, Senior Director Product Marketing, ValGenesis• Recent technology advancements that are promising and problematic?• Learning from our past mistakes – How catastrophes became the catalyst for regulatory action• Assessing our current risk management process(es)• Establishing governance for advanced technologies• Knowing who’s ultimately responsible, and how to protect yourself and your companyTakeaway Tools• […]
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