Every complaint — captured, investigated, defensible.

Capture, triage and investigate market complaints with full regulatory reportability. Trend across products, batches and markets with one connected workflow.

What you can achieve

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.”

Pharmacovigilance Lead

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.

How teams use MC in practice

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

Core capabilities

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.

Compliance baked in

Designed to support the standards you’re audited against.

21 CFR Part 1121 CFR Part 803 (MDR)EU MDR VigilanceEU GMP Annex 11ICH Q10ALCOA++

See MC on your own data.

Bring a real scenario from your operations — we’ll show you exactly how Market Complaint handles it.