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| Regulation, Specification, or Guidance
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Requirement
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21 CFR Part 129.80 (g)
ASTM E1578-18 E-5-1
USDA Sampling Procedures for PDP 5.6–7
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12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
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21 CFR Part 212.61 (a)
21 CFR Part 211.166 (b)
ASTM E1578-18 E-5-2
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12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
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| ASTM E1578-18 E-5-3
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12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
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| ASTM E1578-18 E-5-4
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12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
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| ASTM E1578-18 E-5-5
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12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
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