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| Regulation, Specification, or Guidance
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Requirement
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| ▪ ASTM E1578-18 E-15-1
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20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
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▪ ASTM E1578-18 E-15-2
▪ FDA Hazard Analysis Critical Control Point Principle 1
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20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.
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▪ 21 CFR Part 211.42 (b)
▪ ASTM E1578-18 E-15-3
▪ FDA Hazard Analysis Critical Control Point Principle 1
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20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.
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