The 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.
Join FDA’s Francisco Vicenty and Axendia’s Daniel R. Matlis for a live webinar on March 7th at 1:00 PM ET.
We will discuss FDA’s perspective on Computer Software Assurance (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
Can't make this time? Register and you will be able to watch the On-Demand recording after the event.