Every process, equipment or document change — assessed, approved and traced.
Change Management captures a proposed change, runs it through a templated impact and risk assessment, routes it for role-based approval, and tracks implementation through to the evidence that closes it — with automatic links to any re-qualification, training or document revision the change requires.
Change control is a named pillar of the Pharmaceutical Quality System.
A change that isn't properly assessed is one of the most common root causes behind a later deviation — which is why change control gets its own explicit expectation in ICH Q10.
Written Procedures; Deviations
Requires written procedures for production and process control changes, and that changes be drafted, reviewed and approved before implementation.
Change Management System
Names change management as one of the four core Pharmaceutical Quality System elements, with an explicit expectation of risk-based impact assessment before approval.
Qualification & Validation
A change to a qualified process, system or piece of equipment may trigger re-qualification or re-validation — this module flags that link automatically.
Quality Risk Management
Impact and risk assessment for a proposed change should be documented and proportionate to its potential effect on product quality.
Change control that catches downstream impact automatically.
Most change-control failures aren't in the approval step — they're in the thing nobody remembered to update afterward.
Templated impact assessment
A consistent risk-scoring template means two similar changes get assessed the same way, by whoever happens to review them.
Downstream tasks generated automatically
A change can automatically create linked tasks for re-qualification, document revision or training — so nothing gets forgotten after approval.
Configurable, role-based approval
Route a change through exactly the sign-off chain your SOP requires, with each approval individually signed and timestamped.
A complete history, not just a form
What changed, why, who approved it and what evidence closed it out — all on one record, permanently.
See a change from proposal to closed-out evidence.
We'll show impact assessment, approval routing, and how a change automatically flags re-qualification and training tasks — using a change type from your own site.