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    Quality & RiskQuality System

    Document Control

    Procedures ensuring approved, current documents are used and obsolete copies removed.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Document control under 21 CFR 820.40 and ISO 13485 clause 4.2.4 requires review and approval of documents before issue, identification of revisions, availability at points of use, and prevention of unintended use of obsolete documents.

    What this means in practice

    Most QMS-driven inspection findings touch document control. Electronic QMS (eQMS) systems with versioning, e-signatures, and access control are standard for scaling manufacturers.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1MDIC·1FDA·1
    1. 1
      21 CFR 820.40
      Verified
      eCFRecfr.gov
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

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