Change Control Software
Know what a change triggers.

See comparable past changes and the validation work this one may trigger. A named person decides.

Change Control module in the Lead AI Platform
Supported workflowChange Control

Why teams come
to us for this.

In pharmaceutical change control, a form and memory miss the qualification and validation work a change can trigger.

  • Comparable changes in view during assessment
  • Triggered validation work made visible
  • An attributable decision with its evidence attached

GxP change management, grounded in the changes you have already made.

01

Comparable-change retrieval

Related changes and their recorded effects, from your own history.

Change Control — Comparable-change retrieval
02

Impact assessment support

Evidence organised around the change, so impact is reviewed systematically.

Change Control — Impact assessment support
03

Qualification and validation prompts

Triggered qualification and validation work, flagged for human confirmation.

Change Control — Qualification and validation prompts
04

Accountable decision record

The system proposes and cites; a named person decides — on record.

Change Control — Accountable decision record

Built for

Change ownerQuality assuranceValidation leadership

The rest of the Quality & Manufacturing

Want Change Control running on your data?

Tell us the process or prediction you need. We'll map it to a module, a deployment and an honest timeline.

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