Hello Computer System Assurance (CSA)!
By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate
FDA supports and encourages the use of automation systems and digital technologies throughout the product lifecycle to improve patient outcomes and reduce the risk to patients. It is a common misconception that extensive testing and documentation is required to demonstrate the validation of computer software used in automation.
The FDA, recognizing industries CSV challenges, has announced new guidance on “Computer Software Assurance for Manufacturing, Operations and Quality System Software.” This guidance is on the Agency’s “A-list” and is planned for release in FY 2019.
The content is this eBook represents Axendia’s analysis and opinions on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” based on the following trusted sources:
- Axendia’s interaction with FDA representatives on this topic
- Content and material sourced from FDA
- First-hand experience from Axendia’s clients on the implementation of CSA
- Why Critical Thinking is the Foundation of CSA
- How to Implement a Risk-Based Approach to CSA
- The Objectives of CSA
- What the CSA Landscape Looks Like
- Acceptable Levels of Assurance
Webinar also now available on-demand: Understanding the FDA’s New Approach to Computer System Validation.