Issues/Change Controls Validation Guide
Objective: Ensure the workflow is properly defined to meet its intended purpose.
Validation Items:
- Permissions: Confirm that user access is correctly configured. Users must have at least read-only access to be assigned to the workflow.
- Workflows: Review each step of the Process to ensure transitions are valid and logical.
- High-Risk Areas: Pay special attention to complex stages or sensitive transitions.
- Exit Process: Ensure a proper method exists to close or cancel workflows if needed.
How to Validate:
- Use test or dummy accounts with varying roles and permissions.
- Consider using multiple users when testing complex processes.
- Validate stage transitions, visibility, and access rights.
- Take and save screenshots to document successful validation steps.
Key Considerations:
- Are users required to sign multiple times within the same workflow?
- Are there any loops in the workflow (e.g., transitions from Stage 3 back to Stage 2)? Note: Loops are not supported in ZenQMS and will result in errors.
- Have all permissions been set appropriately?
- Is there a Cancel Stage in place for workflows that may need to be discontinued?