Computerized System Risk Assessment Checklist
A practical structure for assessing system and function-level risk without generating a spreadsheet nobody uses.
What's inside
- System-level GxP impact determination
- Function-level severity, probability and detectability inputs
- Control identification: technical, procedural and supplier
- Assurance activity mapping from risk outcome
- Residual risk acceptance and approval
- Reassessment triggers
Who it's for
CSV/CSA practitioners, system owners, QA