Complaints & PMS

Log the complaint, investigate, flag reportable events, and link CAPA and batches.

View pricing

app.rapidfacto.com / complaints / CMP-2025-012

Packaging seal failure · Stent delivery system

ISO 13485 · 8.2.2 · Batch BMR-2025-041

CriticalReportable

Complaint workflow

Complaint received
Customer · device malfunction
Investigation
Assigned to QA · due 5 days
Root cause analysis
Seal integrity failure identified
CAPA linked
CAPA-051 · corrective action open
5
Regulatory report
CDSCO vigilance · reportable event
CDSCO

Linked to QMS

CAPA-051 · SOP-012

Traceable

Manufacturers using RapidFacto

Trusted by 30+ medical device manufacturers

Post-market surveillance is not a mailbox. RapidFacto logs the complaint, keeps the investigation on the same record, and ties it to the batch and to CAPA when the field issue needs one.

Complaints tied to batch and CAPA

A field issue reaches the batch without a spreadsheet lookup
CAPA is optional in process — not optional in the record
Trends are visible at management review

app.rapidfacto.com / complaints / CMP-2025-012

Packaging seal failure · Stent delivery system

ISO 13485 · 8.2.2 · Batch BMR-2025-041

CriticalReportable

Complaint workflow

Complaint received
Customer · device malfunction
Investigation
Assigned to QA · due 5 days
Root cause analysis
Seal integrity failure identified
CAPA linked
CAPA-051 · corrective action open
5
Regulatory report
CDSCO vigilance · reportable event
CDSCO

Linked to QMS

CAPA-051 · SOP-012

Traceable

Capabilities

What your team uses in RapidFacto

Illustrated from the live product — each module below stands on its own.

app.rapidfacto.com / complaints / CMP-2025-012

Packaging seal failure · Stent delivery system

ISO 13485 · 8.2.2 · Batch BMR-2025-041

CriticalReportable

Complaint workflow

Complaint received
Customer · device malfunction
Investigation
Assigned to QA · due 5 days
Root cause analysis
Seal integrity failure identified
CAPA linked
CAPA-051 · corrective action open
5
Regulatory report
CDSCO vigilance · reportable event
CDSCO

Linked to QMS

CAPA-051 · SOP-012

Traceable

Post-market

Complaints & surveillance

Customer complaint intake, investigation, and linkage to CAPA or batch records.

Complaint registration and classification
Investigation workflow and responses
Trend visibility for management review

app.rapidfacto.com / capa / CAPA-047

CAPA-047

Action phase

Root cause: Calibration drift

2 actions open · Due 15 Jun

CAPA

From deviation or audit finding through root cause, corrective action, and effectiveness check.

CAPA initiation from complaints, audits, or manual
Action items with owners and due dates
Effectiveness verification before closure
Approval workflow on CAPA closure

Explore other modules

Design controls Documents Change control CAPA Training Audits Risks Suppliers Complaints & PMS QMS Manufacturing Quality control Purchase Stores & inventory Approvals Reports & compliance

CAPA

Corrective and preventive action — from deviation or audit finding through root cause, action, and effectiveness check.

QMS

ISO 13485 QMS software — document control, CAPA, training, internal audit, logbooks, complaints, and management review for medical device manufacturers.

Manufacturing

Digital batch manufacturing records, IPQC, finished good testing, and batch release for medical device manufacturers — ISO 13485 and CDSCO audit-ready.