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, which is typically 5 years from the date of manufacture plus the expected lifetime of the device, or longer for implantable and life-sustaining devices (often 10+ years or the lifetime of the device). The specific retention period must be defined in the quality system documentation and justified based on device risk classification.; and
- Accessible to ANVISA inspectors on request.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.