Start Approval Routes in Defect module

Owned by Henry Farris (Unlicensed)
Last updated: Mar 02, 2022 by Tim Hartman
2 min read

Users can submit defects for approval by starting an approval route. Reference Starting an Approval Route and Configuring an Approval Route of this user guide for more information about starting and configuring approval routes.

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Default Role(s)

Defect Manager, Tester

Record Type(s)

Defects

Starting Workflow State(s)

For Defect Manager: New, Open, Ready to Verify, Deferred
For Tester: Ready to Verify

Ending Workflow State

Routing for Approval

Special Rule(s)

  1. The GxP field must by Y.
  2. The Category field must not be blank.
  3. The Analysis field must not be blank.
  4. The Verification Evidence field must not be blank.
  5. The Resolution field must not be blank.
  6. The Resolution Type must be one of: Code Change, Configuration Change, Documentation Update, Externally Resolved, User Training, Workaround Implemented, or Other. (See Below)
  7. The record will become locked against editing.
  8. The Approval Route field will be updated with the new route information.
  9. The Pending Tasks field will be updated with the Level 1 task information.
  10. The Rejection Reason field will be cleared when the route is started.
  11. The record will automatically transition to Closed after the route is complete. The Approved field will be updated to Y at this time.
  12. The record will automatically transition to Rejected if the route is rejected.
  13. First-level task assignee's will receive an email notification.


If the defect GxP field is N, the defect cannot be routed for approval. Non-GxP defects may be directly closed without approval. (Reference Close Defect)

If the defect GxP field is Y, valid values for routing a defect for approval are:

  • Code Change: The resolution resulted in a change in the application code.
  • Configuration Change: The resolution resulted in a change in the application configuration.
  • Documentation Update: The resolution resulted in a change to one or more documents (ex. SOP, User Guide).
  • Externally Resolved: The resolution was resolved externally (ex. another project, vendor).
  • Other (Use Resolution): The resolution is explained in detail in the Resolution entry (this option may be used if more than one type is applicable).
  • User Training: The defect was resolved by adding or updating user training.
  • Workaround Implemented: The defect was resolved by implementing a workaround (ex. a limitation on how a feature is used).