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| Regulation, Specification, or Guidance
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Requirement
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▪ 21 CFR Part 58.105 (a)
▪ 21 CFR Part 211.80
▪ 21 CFR Part 225.102
▪ 21 CFR Part 226.102
▪ ASTM E1578-18 E-4-1
▪ EPA ERLN Laboratory Requirements 3.3
▪ EPA ERLN Laboratory Requirements 4.10.1
▪ OECD GLP Principles 6.2
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11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
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▪ 21 CFR Part 211.80
▪ 21 CFR Part 225.102
▪ 21 CFR Part 226.102
▪ ASTM E1578-18 E-4-2
▪ EPA ERLN Laboratory Requirements 4.10.1
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11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.
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▪ 21 CFR Part 211.80
▪ 21 CFR Part 225.102
▪ 21 CFR Part 226.102
▪ 21 CFR Part 820.65
▪ ASTM E1578-18 E-4-3
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11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.
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| ▪ ASTM E1578-18 E-4-4
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11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.
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| ▪ E.U. Annex 11-15
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11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.
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