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LIMSpec/Lean laboratory and continuous improvement: Difference between revisions

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Latest revision as of 15:04, 19 June 2024

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-15-1 29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
ASTM E1578-18 E-15-2
FDA Hazard Analysis Critical Control Point Principle 1
29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.
21 CFR Part 211.42 (b)
ASTM E1578-18 E-15-3
FDA Hazard Analysis Critical Control Point Principle 1
29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.