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Document Control & Record Keeping

RDC 752/2022 requires a formal document control system covering all quality system documents and records.

Documents (procedures, work instructions, forms) must be:

  • Reviewed and approved before use;
  • Identified with document number, revision level, and effective date;
  • Controlled — obsolete versions removed from points of use;
  • Available at points of use; and
  • Reviewed periodically for continued adequacy.

Records (completed forms, test results, audit reports) must be:

  • Legible, identifiable, and retrievable;
  • Protected from deterioration or loss;
  • Retained for the defined retention period (typically 5–10 years depending on device type); and
  • Accessible to ANVISA inspectors on request.
Official sources

Verify all information against official ANVISA sources before making regulatory decisions.