Every complaint — captured, investigated, defensible.
Built by life science experts to simplify market complaint.
“We went from a spreadsheet and an inbox to a defensible, reportable complaint system in 8 weeks.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Complaint intake
- Capture from web, phone, email or distributor
- Auto-classify by product and complaint type
- Trigger reportability assessment
- Acknowledge complainants on configurable SLAs
Investigation & RCA
- Link to batch records and deviations
- Structured root-cause investigation
- Pull lab results from LIMS when relevant
- Document disposition and corrections
Regulatory reportability
- Assess reportability by jurisdiction
- Generate MDR / Vigilance / FAR drafts
- Track submission status and deadlines
- Maintain a complete reporting history
Trending & PQR
- Trend by product, batch, country and category
- Feed annual product quality reviews
- Identify systemic issues early
- Trigger CAPAs from trend signals
Everything MC ships with.
Multi-channel intake
Capture from any channel into a single queue.
Reportability engine
Decision support for MDR, Vigilance and FAR.
Batch & LIMS linkage
Pull batch and lab data straight into the investigation.
SLA tracking
Configurable SLAs by region and complaint type.
Trend analytics
Detect systemic issues across products and markets.
PQR integration
Roll complaint data into annual product quality reviews.
Designed to support the standards you’re audited against.
See MC on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Market Complaint handles it.