Computer Software Assurance (CSA) Guidance Learn how the FDA's CSA framework modernizes software assurance in life sciences. Focus on risk-based testing, quality improvement, and patient safety. Sandy Hedberg - February 3, 2022 White Papers Biotech, Medical Device, Pharma Clinical, Information Technology, Manufacturing, Quality Assurance, Regulatory
How to Maximize Your GxP Use of the Public Cloud – Video Video on How to Maximize Your GxP Use of the Public Cloud. Stepheni Norton - February 3, 2022 Videos Biotech, CMO, CRO, Medical Device, Pharma Information Technology, Regulatory
FAQ: CSV, CSA, and Why the Paradigm Shift This FAQ curates many questions from our customers and attendees to our various webinars with the FDA on the CSA Guidance. Sandy Hedberg - February 2, 2022 Blogs Biotech, CMO, CRO, Medical Device, Pharma Regulatory
Key differences in the requirements for SFDA UDI and US & EU UDI Blog article topic: Key differences in the requirements for SFDA UDI and US & EU UDI. Jay Crowley - January 29, 2022 Blogs Medical Device Manufacturing, Regulatory
Q&A: UDI Registration in EUDAMED Blog article written from the Q&A during the UDI Registration in EUDAMED webinar. Jay Crowley - January 29, 2022 Blogs Medical Device Regulatory, Safety
FDA Perspectives on Cloud Technologies Watch Session 3 of USDM's virtual event with FDA insights on cloud technologies, CSA guidance updates, and case studies in modern automation. Jim Macdonell - January 28, 2022 Videos Biotech, CMO, CRO, Medical Device, Pharma Information Technology, Regulatory
