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| Regulation, Specification, or Guidance
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Requirement
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▪ 21 CFR Part 211.25 (c)
▪ ACMG Technical Standards for Clinical Genetics Laboratories B2
▪ ASTM E1578-18 E-14-1
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19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.
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| ▪ ASTM E1578-18 E-14-2
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19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
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| ▪ ASTM E1578-18 E-14-3
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19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.
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| ▪ 42 CFR Part 493.1274 (d)
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19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.
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