Audit ready beats audit nervous.
Faster CAPA execution with structured workflows, embedded intelligence, and dynamic traceability. LuminLogic IQ summarizes investigations, drafts root cause aligned to global standards, and surfaces what auditors actually look for: all from inside the workflow.
Investigations, action management, and effectiveness in one workflow.
Every CAPA inherits the same workflow engine, 21 CFR Part 11 signatures, and audit trail as every other content type. Linkage to complaints, change requests, and DDF records is native, not a stitched-together export.
Structured investigations
5 Whys, Fishbone, or Fault Tree: IQ drafts a root-cause statement aligned with FDA expectations, paired with corrective and preventive actions.
Effectiveness verification
Built-in effectiveness checks with configurable criteria, sample sizes, and verification windows: closed by signature, not by note.
Linked across the lifecycle
CAPAs link natively to complaints, change requests, DDF records, training assignments, and SOPs. Traceability is a property of the platform.
21 CFR Part 11 signatures, everywhere they belong
Author, Review, Approve, Concur: bound cryptographically to the record revision, with meaning and intent captured at the moment of signing.
Live KPI dashboards
Open vs. overdue, time-to-close, cycle time by source, recurrence by product: saved views drill into the underlying records, not a stale export.
LuminLogic IQ embedded
Suggest Root Cause, Summarize Folder, Gap Analysis vs. 21 CFR Part 820, every IQ interaction logged to the audit trail next to the record it touched.
A CAPA, from open to closed.
Step through the record the way your team will, investigation, root cause, actions, and effectiveness, all in one workflow.
Open, classify, and understand: fast.
Triggered from a complaint, NCR, or audit finding. LuminLogic IQ summarizes the issue, links related records, and recommends an investigation method.
- Severity & product classification drive routing
- Linked records assemble the evidence base
- IQ drafts the summary, you stay in control
Structured analysis, not guesswork.
Work the root cause with 5 Whys, Fishbone, or Fault Tree, with the evidence right beside you and every step captured to the audit trail.
- Method-guided analysis
- Evidence linked to each step
- Root cause captured to the audit trail
Actions with owners, dates, and gates.
CAPA actions become assigned items with owners, due dates, and 21 CFR Part 11 signature gates, and stay linked to the complaints and changes they touch.
- Clear ownership and due dates
- 21 CFR Part 11 signature gates
- Dynamic links across records
Prove it worked, then close.
Verify effectiveness against configurable criteria, check for recurrence, and route closure for signature: locked to the audit trail.
- Configurable effectiveness criteria
- Trend check for recurrence
- Signed closure, locked record
Every CAPA, in one live view.
Open vs. overdue, cycle time, on-time closure, and the records behind them. Saved views drill straight into the live record, and IQ surfaces shared root causes across the queue.
A CAPA, end to end.
Out-of-the-box workflow ships ready for ISO 13485 and 21 CFR Part 820, and admins can tune it themselves. No consultant required.
Open & classify
Triggered from a complaint, NCR, audit finding, or directly. Severity, source, and product classification drive routing.
Investigate
IQ-assisted root cause with 5 Whys, Fishbone, or Fault Tree. Linked records assemble the evidence base automatically.
Act
Corrective and preventive actions become assigned action items with owners, due dates, and signature gates.
Verify & close
Effectiveness verification with configurable criteria. Closure routed for signature and locked to the audit trail.
“LuminLogic is more than a compliance tool. It’s a system that brings structure and organization to how we run our entire company. It enables us to manage everything from engineering and design records to complaint handling and CAPAs, all in one validated, secure platform.”
CAPA lives on the same platform as everything else.
Complaints
Intake, triage, and MDR / vigilance decision-support: linked directly to CAPAs and DDF.
Learn moreChange Control
CRs with impact assessment and cross-functional routing, admin-configurable workflows.
Learn moreDocuments
Controlled authoring, review, QA and medical-affairs approval, retraining on release.
Learn moreTraining
Role-based assignment, auto-retrain on document release, 21 CFR Part 11 completion records.
Learn moreMove from reactive to ready.
Walk through LuminLogic CAPA with one of our regulatory experts. No slides, just the platform.