The Complaint Register
All complaints are listed with type/subtype, product/lot, site, severity, status, and date received. A consistent complaint process matters to regulators — they look at how you capture, classify, investigate, and resolve complaints. Review the register regularly so complaints don’t stall.Set up your taxonomy (once)
Before logging complaints, define your controlled taxonomy on Complaints → Taxonomy: add complaint types (for example, Packaging, Product quality, Distribution) and a set of subtypes under each. Classifying against a controlled taxonomy — rather than free text — is what makes your complaint trends consistent and reportable.Create the complaint
- Go to Complaints → New complaint.
- Record the source channel, product/lot, and site.
- Capture the complainant details (or mark the complaint anonymous).
- Classify it against your taxonomy (type → subtype) and set the severity.
- Save. The complaint is created and the creation is captured in the audit trail.
Investigate and link corrective action
These actions require Complaints to be enabled and the relevant permission for your role.- Select Start investigation. Wait for the request to finish before another action.
- Open Link disposition, or Raise required CAPA if the complaint requires a CAPA.
- To reuse an existing record, select Attach existing records and choose by number and title from the deviation and CAPA pickers. Only the current organization’s available records are offered.
- Otherwise, complete the linked-record creation fields in the dialog.
- Submit and confirm that the selected disposition appears on the complaint.
Close the complaint
Record a resolution summary and move the complaint to closed. Every state change is written to the tamper-evident audit trail automatically.This guide reflects what is built today: intake, controlled taxonomy, complaint-to-CAPA linkage, and
severity/status tracking to closure.