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Compliance events

Compliance events provide a controlled record for deviations, incidents, exceptions, investigations, and related follow-up.

Create an event

Record the event promptly with:

  • clear title and category;
  • affected batch, sample, protocol, workflow, material, or other entity;
  • date and time discovered;
  • factual description;
  • immediate containment;
  • reporter and responsible owner;
  • supporting files or evidence.

Review and closeout

Follow the organization’s procedure for impact assessment, root-cause analysis, corrective and preventive action, effectiveness checks, and approval. Do not edit historical facts to make a record appear resolved; add subsequent findings and decisions through the supported event workflow.

Alerts versus events

An overdue alert identifies an operational condition. A compliance event is a formal quality or compliance record. Organizations should define when an alert must be escalated into an event.