Skip to main content
Manage changes to processes, equipment, materials, and documentation through a structured approval workflow — ensuring no uncontrolled changes affect product quality.

​
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.