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Complaint records capture product complaints from initial intake through investigation and closure, with a controlled taxonomy for consistent trending and a linked CAPA where corrective action is required.

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Complaint Register

All complaints are listed with their type and subtype, product/lot, site, severity, status, and the date received. Filter and review the register regularly so open complaints are investigated and closed in a timely way.

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Controlled Taxonomy

Complaints are classified against a controlled, two-level taxonomy (type → subtype) that your organization manages on the Complaints → Taxonomy page. Using a controlled taxonomy — rather than free text — is what makes complaint trends consistent and reportable over time.

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Complaint Detail

The detail page captures the complaint source channel, product/lot and site, complainant information, severity, taxonomy classification, current status, a linked CAPA where follow-up action is needed, and a resolution summary on closure. Link a complaint to a CAPA when corrective or preventive action is required so the follow-through is tracked to completion.

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Lifecycle & Audit

Complaints move through a structured lifecycle to closure, and every create and state change is written to the tamper-evident audit trail automatically — giving you an attributable record of who did what and when.
This page describes what is built today. Complaint intake, controlled taxonomy, complaint-to-CAPA linkage, and severity/status tracking to closure are available where Complaints is enabled and your role permits them.
For the end-to-end procedure, see Log a complaint. When Complaints is enabled and your role permits the action, open Link disposition (or Raise required CAPA when prompted). Select Attach existing records, then choose the deviation or CAPA by its number and title. The pickers use records from your organization and exclude records already linked to that complaint. You do not need to paste an internal record ID. Start investigation is disabled while its request is in progress. A refusal appears with the action that failed; it is not carried into an unrelated dialog. Read the message, confirm the current record state, and correct the cause before retrying. These controls do not bypass the existing complaint, role, signature, or closure requirements. Email/web intake and automatic complaint triage remain outside this manual workflow.