21 CFR Part 58 - Good Laboratory Practice (GLP)
Records and Reports (Subpart J)

21 CFR Part 58 - Good Laboratory Practice (GLP) 58.195: Retention of Records

Documentation records, raw data, and specimens must be retained for periods specified including five years following marketing application approval or two years following submission date.

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This control maps to 1 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.

  • 211.180 General Records Requirements

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Other controls in Records and Reports (Subpart J)

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