Experts from IBM and Axendia shared the Journey to CSA in “Welcome to Wednesday” Maximo Event. FDA’s Computer Software Assurance (CSA) draft guidance is intended […]
Journey from Computer Software Validation (CSV) to Computer Software Assurance (CSA) Read More »
Experts from AstraZeneca, Axendia and Tulip Interfaces shared how to move beyond a traditional validation approach and its reliance on non-value-added documentation to unblock your
Computer Software Assurance for Production and Quality System Software The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a
FDA Releases New Draft Guidance on CSA Read More »
Computer System Assurance in Support of Manufacturing 4.0 By: Daniel R. Matlis, President Computer System Validation (CSA) is a streamlined approach to validation that supports
eBook: CSA – A Streamlined Approach to Validation Read More »
Critical thinking is the foundation of Computer System Assurance (CSA). The content in this eBook, sponsored by Sparta Systems, represents Axendia’s analysis and insights on
Goodbye CSV…Hello CSA? eBook Read More »
Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in Life-Sciences. This new approach may result in a 30% to
CSA: A Streamlined Approach to Validation eBook Read More »
IDBS Briefing Note Axendia was recently briefed by Liz Tyler, VP of Customer Operations, and Jim Brooks, Lead Platform Product Manager – GxP Strategy, at IDBS, a Danaher
Unlocking the Power of Data to Accelerate Time to Market Read More »
Axendia’s 2024 Life Sciences Industry Radar Axendia unveiled its fifth annual Life Science Industry Radar on February 15, 2024, during a live “Straight from the Source”
Plotting a Course to Success in the Age of Price Negotiations Read More »
FDA DIGITAL TRANSFORMATION SYMPOSIUM 2023 EVENT BRIEF “The future is already here- it’s just not evenly distributed,” declared William Gibson. Axendia published the “FDA’s e-Transformation
At FDA, The Future Is Already Here Read More »
Körber Business Area Pharma Connext Software Summit 2022 Event Brief Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, delivered the keynote address at Connext North America
Entering a New Dimension with PAS-X Read More »
