Revolutionizing Systems Compliance: Increasing System Quality and Reducing Costs Through Adaption of The Current FDA CSA Guidance

Every computerized system used in regulated Life Sciences activities, including by CROs/CDMOs, device manufacturers, and pharmaceutical companies, must meet U.S. FDA and international regulations. These require systems to be high-quality, fit for use, compliant, and ensure electronic data integrity. More often than not, current validation and compliance practices result  in costly and burdensome projects, and often lead to uncertain compliance, increasing regulatory risks and negatively impacting the business.

To address these challenges, the FDA introduced the "Computer Software Assurance for Production and Quality System Software" Draft Guidance (FDA CSA), steering the industry towards enhancing systems quality, streamlining processes, and cutting costs and time. Expected to take effect this year, FDA CSA has the potential to revolutionize validation and compliance. However, many companies struggle to interpret and implement its principles, and to seize opportunities to drastically improve their compliance and quality assurance practices, and overall ways of doing business.

The Oxenham Group has partnered with Paul Labas, an industry leader with over 25 years of experience, to share insights on FDA CSA guidance and its practical implementation with their clients.

Since 2020, Paul has focused on FDA CSA, presenting at top industry conferences, collaborating with FDA authors, and earning recognition from organizations like ISPE GAMP, KENX, and Temple University’s QA/RA Master’s Program.

Join us on February 25, 2025, as Paul presents a case study on transitioning from outdated CSV practices to a modern, CSA-focused framework. He’ll outline key FDA CSA components and practical steps to improve quality systems, save time, and reduce costs. This session is essential for quality, IT, and business professionals looking to enhance compliance and transform operations. Don’t miss this chance to learn from an industry expert.