Template:LIMSpec/Batch and lot management

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Regulation, Specification, or Guidance Requirement

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

11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.

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

11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.

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

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.
ASTM E1578-18 E-4-4 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.
E.U. Annex 11-15 11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.