Your QMS shouldn't need managing.
Modernize quality operations with a system built for real execution, not static record keeping. CAPAs, complaints, training, audits, and change control share one workflow engine and audit trail, with Analytics and LuminLogic IQ surfacing the cross-record picture you used to keep in your head.
One record set, one audit trail, the cross-record picture in a click.
CAPAs, complaints, training one system.
Every quality record on shared infrastructure, with live KPIs and IQ surfacing the patterns, so quality is real execution, not static record keeping.
Quality management as a connected system not a binder of modules.
Modules in LuminLogic share the workflow engine, the audit trail, and the IQ surface. The cross-record picture is one click, not five tools and a spreadsheet.
Investigations that connect
CAPAs link natively to complaints, change requests, supplier records, and DDF items. Traceability is a property of the platform.
KPI dashboards
Open vs. overdue, cycle time by source, recurrence by product: saved views drill into the records, not a stale export.
Loops that close
Effectiveness verification with configurable criteria and 21 CFR Part 11 closure. The audit trail records both intent and outcome.
People stay in sync
Retraining triggers on release. Competency dashboards surface gaps. Workflows route to the right approvers automatically.
One platform, not five tools
CAPA, complaint, change, training, audit, same engine, same data model. No copy-paste status between systems.
LuminLogic IQ embedded
Suggest root cause, summarize a folder, gap-analyze against framework: citations log to the record’s audit trail.
The full QMS, in one platform.
CAPA
Investigations, action management, and effectiveness, in one workflow.
Learn moreComplaints
Intake, triage, MDR / vigilance: clocks tracked natively.
Learn moreTraining
Role-based, auto-retrain on release, 21 CFR Part 11 completion.
Learn moreDocuments
Controlled SOPs and work instructions with QA and medical-affairs review.
Learn moreQuality doesn't live in a silo.
CAPAs, complaints, submissions, change requests, and the DDF share one workflow engine and one audit trail, so quality sees the whole picture, live.
See your QMS run as one thing.
Walk through a real CAPA-complaint-change loop with one of our regulatory engineers.
We’ve been working with MethodSense since 2016, and their guidance has been pivotal to our growth as a medical device manufacturer. I would unequivocally recommend MethodSense and LuminLogic to any medical device company looking to streamline their quality and regulatory processes and achieve operational excellence.
Rebecca Schild
Director of Regulatory and Quality Operations, Zenith Technical Innovations