Computer Software Assurance Readiness Checklist
CSA fails when it is adopted as a vocabulary change rather than a framework change. This checklist tests organizational readiness.
What's inside
- Policy and SOP updates required to authorize risk-based assurance
- Intended use and risk determination worksheet structure
- Assurance activity selection guidance by risk level
- Evidence expectations for unscripted testing
- Reviewer and approver training considerations
- Interfaces to Part 11, data integrity and change control
Who it's for
Quality systems owners, CSV leads, IT quality