21 CFR Part 211 - Current Good Manufacturing Practice
Records and Reports

21 CFR Part 211 - Current Good Manufacturing Practice 211.180: General Records Requirements

Records required by Part 211 must be retained for at least one year after expiration date of the batch. Records must be readily available for authorized inspection.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 3 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 58.190 Storage and Retrieval of Records and Data
  • 58.195 Retention of Records
  • 58.51 Specimen and Data Storage Facilities

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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The graph holds this control, the 3 it maps to, and the evidence behind each claim, over MCP and REST.