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| Regulation, Specification, or Guidance
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Requirement
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| ASTM E1578-18 E-8-1
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15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
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21 CFR Part 212.60 (d)
ASTM E1578-18 E-8-2
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15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.
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21 CFR Part 211.84
21 CFR Part 211.101
21 CFR Part 212.60 (d)
21 CFR Part 226.80
21 CFR Part 606.120 (b)
29 CFR Part 1910.1030 (g)
29 CFR Part 1910.1096 (e-6)
29 CFR Part 1910.1200 (f-6) and (f-10)
ASTM E1578-18 E-8-3
WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41
WHO Technical Report Series, #986, Annex 2, 15.10–12
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15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.
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21 CFR Part 212.40 (c)
21 CFR Part 820.50
ASTM E1578-18 E-8-4
USDA Administrative Procedures for the PDP 7.1
WHO Technical Report Series, #986, Annex 2, 14.8
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15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.
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21 CFR Part 211.196
21 CFR Part 212.90
21 CFR Part 225.110
21 CFR Part 606.165
29 CFR Part 1910.1450 Appendix A (I)
ASTM E1578-18 E-8-5
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15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.
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21 CFR Part 211.82 (b)
21 CFR Part 211.84 (a)
21 CFR Part 211.89
21 CFR Part 211.110 (d)
21 CFR Part 211.142 (a)
21 CFR Part 212.40 (c)
ASTM E1578-18 E-8-6
WHO Technical Report Series, #986, Annex 2, 12.18
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15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.
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