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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
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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, 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
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2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
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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 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
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
USDA Administrative Procedures for the PDP 8.5
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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