View source for LIMSpec/Batch and lot management

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  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
  | style="background-color:white;" |'''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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[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
  | style="background-color:white;" |'''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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[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-3]
  | style="background-color:white;" |'''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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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-4]
  | style="background-color:white;" |'''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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  | style="padding:5px; width:500px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15]
  | style="background-color:white;" |'''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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