Changes made informally.
Impact assessed after the fact.
Every change requested, assessed, approved, and tracked before implementation.
Every change requested, assessed, approved, and tracked before implementation.
The problem
Process and product changes made without formal change requests or impact assessments
Changes approved without understanding downstream effects on processes, documents, or training
Change requests stuck in email - nobody knows who needs to approve or where it stands
Change approved but implementation tasks (document updates, retraining) never completed
The solution
Every change starts with a request including rationale, scope, and risk classification
Structured evaluation of impact on products, processes, documents, and regulatory filings
Automatic routing to the right approvers based on change type and risk level
All downstream tasks (document updates, training, validation) tracked to completion
Connects to document control and training modules - approved changes automatically trigger downstream updates
Capture the proposed change with classification, rationale, and supporting evidence
Evaluate effects on products, processes, documents, training, and regulatory status
Automatic routing to change control board or designated approvers
Monitor all downstream tasks until change is fully implemented and verified
Average approval cycle
Changes with impact assessment
Untracked implementation tasks
Change history for auditors
Needs formal change control processes that satisfy ISO 13485 clause 7.3.9
Need to submit changes efficiently without getting stuck in approval queues
Need to assess whether changes trigger new regulatory submissions
Structured change control with impact assessment and implementation tracking - configured in 21 days.