Description:
This Record Control Procedure defines how we identify, approve, protect, store, retrieve, and retain QMS records to preserve integrity, security, and retrievability.

• Apply a unique record number and revision per the defined identification system.

• Follow good documentation practices (legible/complete/accurate, permanent ink, YYYY/MM/DD, “N/A” for blanks).

• Ensure records are approved per the RRM, with signed author/approver and dated approval blocks.

• Use validated electronic signatures where applicable (e.g., 21 CFR Part 11 needs).

• Control changes to records (single-line strike-through for paper; redline/traceable edits for electronic).

• Store scanned physical records and secure electronic records with access restrictions and backups.

• Define retention and archiving (including MDR 10/15-year expectations) and manage confidential health records under GDPR.

Your needs:

• QMS record control procedure

• QMS record control procedure for ISO 13485 and MDR compliance.

• Reduce rework, prevent data loss, and improve audit readiness.

Use this procedure whenever we create, update, sign, scan, or archive QMS records, including outsourced forms approved for use.

It sets consistent controls. Data integrity means records stay complete, accurate, and unaltered; it matters for defensible decisions. Redline means traceable change marking; it matters for review and re-approval.

• Unique identification and revision control for every record.

• Controlled approvals aligned to the RRM.

• Documented correction rules for paper and electronic records.

• Secure storage, access control, and timely retrieval expectations.

• Defined backup methods (full, incremental, real-time) and restoration steps.

• Retention and archiving rules for obsolete records/documents.

• Confidential health record handling and breach response via CAPA.

At Lexqara, we implement record governance that fits your QMS workflows, supports audits, and strengthens inspection readiness (training, templates, internal audits). Resource Center [https://lexqara.com/resource-center] and QMS Implementation [https://lexqara.com/services/qms-implementation]. 21 CFR Part 11 [https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11]. Request a short gap assessment.

Clear record control reduces approval bottlenecks, protects confidential data, and keeps evidence retrievable across the full product lifecycle.