Keep facility, equipment and process changes under control
From a small part swap to a major process optimization, run every change through a six-stage closed loop: initiate, impact assessment, QA review, actions, verification, closure.
Change Control Management System
Illustrative interface rendering. Real screens and recordings live on the module pages.
Change Control Management System
Who it is for: QA directors, engineering managers, regulatory affairs specialists
Multi-dimensional impact matrix
Has department leads assess a change's effect on validation, equipment/software, the regulatory dossier (CTD), EHS and training at the same time.
Risk classification
Classifies major, minor and emergency changes with a rule set; emergency changes force a retrospective QA approval loop.
Implementation tasks and closure lock
Assigns actions such as SOP writing, IQ/OQ testing and training to people; a change cannot close until every task is done.
Effectiveness verification
Makes a post-implementation check (e.g. after 60 days) mandatory to confirm the expected outcome.