Change Control Register
All change requests with type, impact assessment, status, and approval chain. In GMP manufacturing, every change must be evaluated for quality impact before implementation — uncontrolled changes are a top-10 audit finding. Review pending changes and ensure impact assessments are complete before approval.Impact Assessment
Each change record captures what is changing, why, affected process areas, and expected quality impact. Changes to equipment, process parameters, materials, facilities, or documents can affect validation, training, release criteria, and product quality. Before approval, confirm validation, document updates, training, and implementation timing are addressed.Implementation Evidence
Approved or implemented changes retain the decision trail and any supporting quality evidence. Inspectors expect to see that changes were assessed before use and implemented according to the approved plan. Keep change-control rationale specific and link related deviations, CAPAs, SOP revisions, or training assignments where applicable.Training targets
For a new change control, select training targets from the available groups, users, and platform roles. These selections retain explicit identities rather than matching a person’s name or job-title text. Group and user choices are limited to the current organization. Review the selected targets on the detail page before the controlled implementation step. If a selected group or user is archived or unavailable, the page retains the target information rather than silently hiding it. Resolve the reported problem through your quality administrator; do not assume a different audience was selected. Older change controls can still display legacy free-text team labels. They have not been automatically mapped, renamed, or converted to the new selections. Existing legacy audience handling is unchanged. Training target selection alone does not issue training: the record must require training and reach the applicable implementation workflow, with its existing feature and permission checks. Where a selected target becomes unavailable before implementation (for example, a deactivated user or an archived group), the approval and implementation dialogs list it as skipped. Training goes to every other target that is still available, and the skipped list is included in the implementation signature.Review decisions
While a change control is Under Review, an Administrator or QA Manager can sign one of two decisions besides approval:- Return to author sends the record back to Draft so it can be resubmitted. It needs a Reason for return.
- Reject closes the record permanently as Rejected. A new change control is needed to try again. It needs a Reason for rejection.
Attachments (where enabled)
Where attachments are enabled, the detail page has an Attachments / evidence panel. Select Upload to add a file up to 25 MB. Each file shows its size, type, uploader, time and SHA-256 digest, and Download re-checks the digest. Files cannot be added once the change control is finished (implemented, rejected or closed); raise a new change control if more work is needed. Files are also frozen while an assigned review is in progress. Older file references show under Referenced files. See Attach evidence.Impacted documents (where enabled)
Where impacted-document tracking is enabled, the Impacted documents panel lists the controlled documents the change affects. Choose a Document, a Required action (Revise or Retire) and an optional note, then select Add impacted document. Removing a document asks for a reason. The list can be edited while the change control is open, draft or in pre-review. Each row shows Updated once an approved version of the document dated after the change control exists, or Pending with the version still in force. Retirement is tracked manually. On its own, the list is advisory: it warns before implementation but does not block it.Document closure gate (where enabled)
Where the document closure gate is also enabled, the impacted-document list is frozen into Impacted-document obligations when QA signs the approval. Implementation is then blocked until every obligation is resolved:- A Revise obligation resolves when an approved revision of the document, dated after the change control was created, exists.
- A Retire obligation, or any obligation that will not be met, can be waived by an independent QA Manager or Administrator with a signed Waive and a reason. A waiver can be revoked the same way. The waiver signer must not have edited the impacted-document list.
Assigned approvals (where enabled)
Where assigned approvals are enabled, each change control needs an approver roster before it can be submitted.- On the detail page, in Assigned approvals, select Choose approvers.
- Add 1 to 25 people. Give each a Function label and mark whether their approval is Required.
- Mark exactly one required person as Final QA (QA manager or admin).
- Enter a Reason for this roster and select Save review roster.