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| Regulation, Specification, or Guidance
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Requirement
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| ASTM E1578-18 S-1-1
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31.1 The system shall provide tools to enter and manage user-configurable lookup or master data.
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| ASTM E1578-18 S-1-2
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31.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.
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45 CFR Part 162.1002
USDA Sampling Procedures for PDP 6.3.2
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31.3 The system shall allow system nomenclature to be configured to use specific data code sets—such as the International Classification of Diseases or the Healthcare Common Procedure Coding System—or mandated terminology to support regulatory requirements.
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| ASTM E1578-18 S-1-3
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31.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.
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| ASTM E1578-18 S-1-4
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31.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.
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21 CFR Part 211.100 (b)
21 CFR Part 211.160 (a)
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31.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.
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40 CFR Part 3.10
40 CFR Part 3.2000
ASTM E1578-18 S-1-5
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31.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.
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