Complaints handling, without the missed clock.
Intake from any channel, triage with embedded reportability guidance, and route vigilance submissions on the clock across global frameworks. Link the underlying CAPA and design history natively, in one workflow, not five tools.
On-the-clock complaint handling without losing the trail.
Every complaint inherits 21 CFR Part 11 signatures, the same audit trail, and the same workflow engine as the rest of LuminLogic. Reportability is supported by IQ, not delegated to it.
Channel-agnostic intake
Web form, email-to-case, phone, distributor portal: captured into the same record with attachments and metadata.
Reportability clock
US MDR, EU MDR, Canada MDR. Clocks tick automatically with watchful banners and SLA-aware routing.
Decision-support
IQ surfaces reportability rationale aligned to 21 CFR 803, Annex VI, and similar regional frameworks: every answer linked to citation.
Native CAPA & DDF linkage
Open a CAPA in one click, link to the controlling DDF item and SOP, full traceability without an export.
Trend signals
Recurrence by product, lot, and failure mode. PMS dashboards roll up to a single saved view per device family.
LuminLogic IQ embedded
Suggest event classification, draft regulator narrative, summarize complaint history: each interaction logged to the audit trail.
Intake to vigilance, one queue.
Severity, MDR clocks, geography, and CAPA links in a single view, with LuminLogic IQ supporting reportability and drafting submissions inside the record. The decision stays yours.
One complaint, every clock, at a glance.
LuminLogic IQ evaluates each complaint against every framework you operate under and surfaces the decision, the clock, and the rationale, so nothing slips and nothing is over-reported.
A complaint, end to end.
Out-of-the-box workflow covers US MDR, EU MDR, ISO 13485 §8.2.1 and §8.3: admin-configurable per device family.
Complaints lives on the same platform as everything else.
CAPA
Open and link in one click, investigation traces back to the complaint record.
Learn moreDDF
Link the design risk and failure mode behind the complaint.
Learn moreDocuments
Trigger a procedural revision when a complaint surfaces a gap.
Learn moreChange Control
Promote a fix to a change request with full impact assessment.
Learn moreStop counting clocks in spreadsheets.
See how a complaint flows from voicemail to MDR to closed CAPA on one platform, without re-keying.