Q&A from an Axendia Straight from the Source (SftS) Webinar
By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President
In our recent webinar, we discussed FDA’s perspective on Computer Software Assurance (CSA). FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.
In this “Straight from the Source” webinar, we discussed FDA’s perspective on CSA including:
- FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
- Applying critical thinking and risk-based principles to support technology modernization
- Identifying Acceptable Records of Assurance
- Leveraging CSA to accelerate digital transformation
There were many more questions submitted than could be answered in the time allotted.
Register and receive your internal-use copy of the full Q&A.