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| Regulation, Specification, or Guidance
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Requirement
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▪ ASTM E1578-18 C-2-1
▪ EPA ERLN Laboratory Requirements 4.11.14
▪ SQF FSC 9, Food Manufacturing, Part B, 2.6.2
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2
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2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
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▪ ASTM E1578-18 C-2-2
▪ EPA ERLN Laboratory Requirements 4.11.14
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2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
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▪ ASTM E1578-18 C-2-3
▪ EPA ERLN Laboratory Requirements 4.11.14
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2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
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▪ ASTM E1578-18 C-2-4
▪ EPA ERLN Laboratory Requirements 4.11.14
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2.4 The system shall require the recording of a standard and reagent's first opening date.
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▪ ASTM E1578-18 C-2-5
▪ EPA ERLN Laboratory Requirements 4.11.14
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2.5 The system shall allow only active standards and reagents to be shown as available for use.
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▪ ASTM E1578-18 C-2-6
▪ EPA ERLN Laboratory Requirements 4.11.14
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2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
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| ▪ ASTM E1578-18 C-2-7
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2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.
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▪ ASTM E1578-18 C-2-8
▪ EPA ERLN Laboratory Requirements 3.2
▪ ISO/IEC 17025:2017 7.4.2
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2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
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▪ 7 CFR Part 331.17
▪ 9 CFR Part 121.17
▪ 21 CFR Part 211.84
▪ 42 CFR Part 73.17
▪ ASTM E1492-11 4.2.1
▪ ASTM E1578-18 C-2-9
▪ CAP Laboratory Accreditation Manual
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2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.
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▪ 21 CFR Part 1.1152 (d)
▪ A2LA C211 5.4
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
▪ ASTM E1578-18 C-2-10
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2.10 The system shall be able to link test methods and specifications to standards and reagents.
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▪ 21 CFR Part 1.1138
▪ 21 CFR Part 1.1150
▪ 21 CFR Part 1.1153 (c)
▪ 21 CFR Part 111.315
▪ 21 CFR Part 129.80 (g)
▪ 21 CFR Part 211.84
▪ 21 CFR Part 211.166–7
▪ 21 CFR Part 211.194 (e)
▪ 21 CFR Part 212.40 (c)
▪ 21 CFR Part 212.61
▪ 21 CFR Part 212.70 (e)
▪ 21 CFR Part 225.58
▪ 21 CFR Part 226.58
▪ 21 CFR Part 606.65 (c)
▪ 21 CFR Part 606.151
▪ A2LA C223 5.9
▪ ACMG Technical Standards for Clinical ▪ Genetics Laboratories C6.2
▪ ACMG Technical Standards for Clinical Genetics Laboratories C10–12
▪ CAP Laboratory Accreditation Manual
▪ ASTM E1578-18 C-2-11
▪ EPA ERLN Laboratory Requirements 3.1.2.1
▪ EPA ERLN Laboratory Requirements 4.3.2
▪ EPA ERLN Laboratory Requirements 4.11.3.2
▪ EPA QA/G-5 2.2.5
▪ ISO/IEC 17025:2017 7.7.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ NYSDOH ELAP Medical Marijuana Microbiology Guidance
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)
▪ USDA Administrative Procedures for the PDP 8.5
▪ USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2
▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h
▪ WADA International Standard for Laboratories (ISL) 5.3.7
▪ WHO Technical Report Series, #961, Annex 13, 12.1
▪ WHO Technical Report Series, #986, Annex 2, 17.7
▪ WHO Technical Report Series, #986, Annex 2, 17.22–25
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2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
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| ▪ FDA Q1A(R2)
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2.12 The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.
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