Change requests, with the impact picture built in.
Submit a change request and see what it touches across documents, DDF, supplier records, training, and configuration management. Route it for the right approvers under one configurable workflow with 21 CFR Part 11 signatures, dynamic traceability, and a complete audit trail.
Change control, with the impact picture intact. Without the spreadsheets.
Every record inherits the same workflow engine, 21 CFR Part 11 signatures, and audit trail as every other content type in LuminLogic. Linkage across modules is native, not a stitched-together export.
Admin-configurable workflows
Configure routing, gates, and approver sets per change type, without a services engagement, without a deploy.
Impact assessment, automated
IQ surfaces every record that links to the change, documents, DDF items, training, supplier records, open CAPAs.
21 CFR Part 11 signatures
Approvers sign under intent. Concurrence captured cryptographically against the revision being approved.
Trigger downstream
A released change auto-creates linked actions: SOP revisions, retrain assignments, supplier requalification.
Cycle-time visibility
Live KPIs on open, overdue, and time-to-close, by change type, originator, and product family.
LuminLogic IQ embedded
Draft the impact assessment, summarize the rationale, flag missed approvers, logged inline to the audit trail.
Change Control, end to end.
Out-of-the-box workflow ships ready for ISO 13485 and 21 CFR Part 820, and admins can tune it without a services engagement.
Propose
Originator opens a CR. Type, scope, and product classification drive the workflow path.
Assess
IQ-assisted impact assessment. Linked records assemble automatically; reviewers concur or push back.
Approve
Configurable approver sets sign with intent under 21 CFR Part 11.
Release
Downstream actions auto-created: doc revisions, retraining, supplier requalification, closure routed for signature.
Change Control lives on the same platform as everything else.
Documents
Revision changes route through Change Control with retraining on release.
Learn moreCAPA
A CAPA finding triggers a change request; closure links back.
Learn moreSupplier Quality
Supplier changes route through Change Control with SCAR linkage.
Learn moreEngineering & DDF
Design changes carry impact into V&V, risk, and submissions.
Learn moreA change request, routed and risk-aware.
Raise a CR and LuminLogic assesses impact, routes by risk across Quality, Regulatory, and Engineering, and triggers the downstream actions automatically, with IQ summarizing the blast radius.
See everything a change touches.
Open a change request and LuminLogic maps the blast radius (every linked document, training assignment, supplier, risk, and validation) so nothing downstream is missed.
Stop guessing what a CR will break.
Walk through a real change request with one of our regulatory engineers, see the impact picture assemble itself.