The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The Agency is working swiftly to reverse this trend through the transition to Computer System Assurance (CSA).
In this webinar, FDA’s Francisco Vicenty and Axendia’s Daniel R. Matlis discuss the Agency’s insights on Digital Transformation & Manufacturing Modernization.
Watch this webinar to gain FDA’s perspective on:
- Leveraging CSA to accelerate digital transformation
- Digitally Transforming operations to improve product quality and reduce patient risk
- Applying critical thinking to support manufacturing modernization
- Implementing Review by Exception to enhance quality processes
- Managing Data Integrity with electronic records
- Using Digital Transformation to improve process efficiency and effectiveness