CAPA
CAPAs in ComplereRaise a corrective or preventive action, implement its actions and review whether they were effective.
Tasks
Do a task
Lifecycle
Select a status to see who acts there and the article for that step.
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1Initiated
InitiatedStatus 1 of 9
- Who acts
- InitiatorsCoordinators
- What happens
- The CAPA is saved here. Sign to send it on to Awaiting Approver sign-off.
- Signature
- Yes
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2Awaiting Preliminary Reviewer sign-offOptional
Awaiting Preliminary Reviewer sign-offStatus 2 of 9
- What happens
- Not used on every CAPA.
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3Awaiting Approver sign-off
Awaiting Approver sign-offStatus 3 of 9
- Who acts
- Approvers
- What happens
- Sign to move the CAPA to Authorise Actions Implementation, or send it back to Initiated with a reason.
- Signature
- Yes
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4Authorise Actions Implementation
Status 4 of 9
- Who acts
- QAs
- What happens
- Sign to authorise the actions: the CAPA moves to Implement Actions. Or send it back with a reason.
- Signature
- Yes
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5Implement Actions
Implement ActionsStatus 5 of 9
- Who acts
- CoordinatorsQAs
- What happens
- Each action is carried out and closed by its own Coordinators and QAs, from the Escalate button on its row; an action whose Closure Dependencies are open waits in Awaiting Dependency. When the last action is Closed, the CAPA moves to Awaiting QA sign-off by itself (recorded as Status auto-advanced, not signed).
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6Awaiting QA sign-off
Awaiting QA sign-offStatus 6 of 9
- Who acts
- QAs
- What happens
- Sign to move the CAPA to Awaiting Effectiveness Review; the QAs' panel also offers Escalate status to Closed. Or send it back to an earlier status with a reason.
- Signature
- Yes
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7Awaiting Effectiveness Review
Awaiting Effectiveness ReviewStatus 7 of 9
- Who acts
- Coordinators
- What happens
- Answer Was the action effective? on the Effectiveness tab and sign with Save And Escalate. Yes moves the CAPA to Awaiting Effectiveness Verification; No, with a rejection reason, sends it back to Awaiting QA sign-off.
- Signature
- Yes
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8Awaiting Effectiveness Verification
Awaiting Effectiveness VerificationStatus 8 of 9
- Who acts
- QAs
- What happens
- Sign to close the CAPA, or send it back to Awaiting Effectiveness Review with a reason.
- Signature
- Yes
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9Closed
ClosedStatus 9 of 9
- What happens
- The CAPA is complete; its status button is greyed.
- Signature
- No
Select a status above to see who acts there.
Other moves
- Send backAwaiting Approver sign-offtoInitiatedorAwaiting Approver sign-offApprovers send back to Initiated; QAs to Initiated or Awaiting Approver sign-off. With a reason.How a CAPA moves from Initiated to Closed
- Send backAwaiting QA sign-offtoan earlier statusQAs, with a reason: Initiated, Awaiting Approver sign-off, Authorise Actions Implementation or Implement Actions.How a CAPA moves from Initiated to Closed
- Send backAwaiting Effectiveness ReviewAwaiting Effectiveness Verificationtothe status beforeCoordinators send back to Awaiting QA sign-off (an effectiveness review answered No, with a rejection reason); QAs to Awaiting Effectiveness Review.How a CAPA moves from Initiated to Closed
A dashed status is not used on every record. The QAs' panel in Awaiting QA sign-off also offers "Escalate status to Closed".
Status names and colours as Complere shows them.
The whole workflow, step by step: How a CAPA moves from Initiated to Closed
Who can do what
Who can take the key actions. A status name in a cell means the action is allowed in that status only.
| Your system role | Named on the CAPA | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Action | Administrator | Supervisor | Regular User | Read Only User | Initiators | Preliminary Reviewers | Coordinators | Approvers | QAs |
| Create a CAPA How to: Create a CAPA | Yes | Yes | Yes | No | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action |
| Change the CAPA's details | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | No | No | No | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | No | No |
| Sign to send on from Initiated Read: How a CAPA moves from Initiated to Closed | No | No | No | No | Initiated | No | Initiated | No | No |
| Sign the preliminary review Read: How a CAPA moves from Initiated to Closed | No | No | No | No | No | Awaiting Preliminary Reviewer sign-off | No | No | No |
| Sign to move the CAPA on How to: Sign a CAPA as Approver or QA | No | No | No | No | No | No | No | Awaiting Approver sign-off | , Awaiting QA sign-off, Awaiting Effectiveness Verification |
| Move on from Implement Actions How to: Close a CAPA action Every action must be Closed first; the CAPA then moves on by itself (Status auto-advanced, not signed). The Permissions page still lists this move for Coordinators and QAs. | No | No | No | No | No | No | Implement Actions | No | Implement Actions |
| Record the effectiveness review How to: Record the effectiveness review of a CAPA Signed. An answer of No sends the CAPA back to Awaiting QA sign-off. | No | No | No | No | No | No | Awaiting Effectiveness Review | No | No |
| Send back with a reason Read: How a CAPA moves from Initiated to Closed | No | No | No | No | No | No | Awaiting Effectiveness Review | Awaiting Approver sign-off | , Awaiting QA sign-off, Awaiting Effectiveness Verification |