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| Regulation, Specification, or Guidance
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Requirement
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ASTM E1578-18 E-8-1
CAP Laboratory Accreditation Manual
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
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15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.
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21 CFR Part 212.60 (d)
ASTM E1578-18 E-8-2
CLSI QMS22 2.1.2
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
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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)
40 CFR Part 262.206
ASTM E1578-18 E-8-3
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OSHA 1910.1200(b)(3) and (f)
OSHA 1910.1450(h)
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 117.420
21 CFR Part 212.40 (c)
21 CFR Part 820.50
A2LA C211 4.6
ASTM E1578-18 E-8-4
BRC GSFS, Issue 8, 3.5.1.4
Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2
GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5
IFS Food 7, Part 2, 4.4.1
IFS PACsecure 2, Part 2, 4.4.1
ISO/TS 22002-1:2009, 9.2
ISO/TS 22002-4:2013, 4.6.2
ISO/TS 22002-6:2016, 4.6.2
SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1
SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)
USDA Administrative Procedures for the PDP 7.1
WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3
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)
A2LA C211 4.6
ASTM E1578-18 E-8-5
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)
USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5
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15.5 The system should provide a means for accurately recording the receipt, approval, 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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21 CFR Part 211.89
21 CFR Part 211.110 (d)
42 CFR Part 493.1252 (d)
ASTM E1578-18 E-8-7
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15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.
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21 CFR Part 211.89
ASTM E1578-18 E-8-8
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15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.
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