Implementation, verification and closure

An approved change request is not finished. ISO 13485 (7.3.9) and GMP change control expect the change to be implemented, its effectiveness verified, and the record closed with a signature. The change request detail page records all three stages after approval:

Approved --> In implementation --> Verification --> Closed
                    ^                    |
                    +---- not effective -+

Each stage shows who acted and when, any notes they recorded, the evidence attached for that stage and, for verification and closure, that the step was electronically signed. Every step is also written to the change request’s History.

Who can do what

Stage	Who can act
Start and complete implementation	The requester (owner), the assigned user (implementer), and users with the change-control update or administration permission (Admin and QA_Team by default)
Attach implementation evidence	The same people as above
Verify the change	Users with the change-control verify permission (Admin and QA_Team by default) – but not anyone who worked on the implementation
Attach verification evidence	The same people who can verify
Close the change	Users with the change-control approve or administration permission (Admin and QA_Team by default) – but not anyone who worked on the implementation. The verifier, normally QA, can close

Anyone who can open the record but holds none of these permissions (for example a User or an Auditor named on it) can read it but cannot move it on. If you cannot act on a stage, the page says why under the button.

Start implementation

1. Open the approved change request.
2. In the Implementation stage panel, optionally add a note, then select Start implementation.

The change moves to In implementation, and records you and the time as the start.

Record the implementation

While the change is in implementation:

1. Add and complete the change’s implementation tasks in the Implementation tasks section.
2. In Documents, attach at least one file with the evidence type Implementation – for example the updated SOP, installation record or photographs.
3. In the Implementation stage panel, describe what was done, then select Send for verification.

Send for verification is refused while any implementation task is still open or before any implementation evidence is attached. The page tells you which.

The change moves to Verification. Users who can verify are notified that it is waiting for them.

Implementation tasks

Implementation tasks are a checklist of the work the change requires (for example “Update SOP-BR-001”, “Train shift operators”). They can be added and ticked off while the change is approved or in implementation. Once the change goes to verification they become read-only, so the implementation the verifier checks cannot change underneath them.

Verify the change

Verification checks that the implemented change is effective, using the Verification method recorded on the change request.

1. In Documents, attach at least one file with the evidence type Verification (needed when you record the change as effective). It must be attached after the change was sent for verification: a verification file attached before approval, or in an earlier round that found the change not effective, does not count.
2. In the Verification stage panel, select Record verification & sign.
3. Choose the outcome – Effective or Not effective – and describe what you checked and what you found.
4. Request a verification code, enter the code emailed to you, and sign.

Verification is an electronic signature (21 CFR Part 11) whatever the outcome.

• Effective – the change is ready to close.
• Not effective – the change returns to In implementation with your reason. It cannot be closed until the implementation is completed again and a later verification finds it effective. The earlier verification stays on the record.

Note

No one can verify implementation work they did (two-person rule): not the person who sent the change for verification, not anyone who completed one of its implementation tasks, and not anyone who attached its implementation evidence. Someone else with the verify permission must do it.

Close the change

Once the change has been verified as effective:

1. Optionally attach closure evidence in Documents (evidence type Closure).
2. In the Closure stage panel, select Close change & sign.
3. Optionally add closure comments, request a verification code, enter it, and sign.

Note

No one can close a change whose implementation work they did: not the person who sent it for verification, not anyone who completed one of its implementation tasks, and not anyone who attached its implementation evidence. The change-control administration permission does not override this. The Closure panel tells you why and disables Close change & sign; the verifier or another approver closes it. The implementer supplies the closure evidence, and QA reviews it and approves the closure.

The change moves to Closed – its final state. The record, its tasks and its evidence become read-only. The requester and the assigned user are notified.

Evidence types by stage

Change status	Evidence types you can attach
Draft, Submitted	Assessment, Approval, Verification, Closure
Approved, In implementation	Implementation
Verification	Verification, Closure
Rejected, Closed	None – the record is locked