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| Regulation, Specification, or Guidance
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Requirement
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21 CFR Part 111.315
21 CFR Part 211.84 (d)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1
ASTM E1578-18 C-3-1
CLSI QMS22 2.2.2.1
ISO 15189:2012 5.3.2.7
WADA International Standard for Laboratories (ISL) 5.2.7
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3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
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21 CFR Part 211.84 (e)
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-2
WADA International Standard for Laboratories (ISL) 5.2.7
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3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
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42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-3
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3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
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| ASTM E1578-18 C-3-4
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3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.
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| ASTM E1578-18 C-3-6
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3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
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| ASTM E1578-18 C-3-7
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3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
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| ASTM E1578-18 C-3-8
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3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
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| ASTM E1578-18 C-3-9
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3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
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| ASTM E1578-18 C-3-10
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3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
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AIHA-LAP Policies 2022 2A.7.8.2
ASTM E1578-18 C-3-11
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3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
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| ASTM E1578-18 C-3-12
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3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
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42 CFR Part 493.1241
ASTM E1578-18 C-3-13
EPA ERLN Laboratory Requirements 4.9.11
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3.12 The system should effectively alert users upon entry of out-of-specification test results.
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21 CFR Part 1.1150
21 CFR Part 1.1152 (a–b)
21 CFR Part 1.1152 (d)
21 CFR Part 1.1153 (c)
21 CFR Part 106.100 (c–f)
21 CFR Part 111.110
21 CFR Part 111.325
21 CFR Part 112.161
21 CFR Part 114.100 (a)
21 CFR Part 129.80 (g)
21 CFR Part 211.194
21 CFR Part 212.60 (g)
21 CFR Part 507.202
21 CFR Part 606.160
ACMG Technical Standards for Clinical Genetics Laboratories G16.1
A2LA C223 5.10
ASTM E1578-18 C-3-14
BRC GSFS, Issue 8, 5.6.1.2
BRC GSFS, Issue 8, 9.3.1
BRC GSFS, Issue 8, 9.3.5
CLSI QMS22 2.1.2
CLSI QMS22 2.2.2.1
EPA ERLN Laboratory Requirements 3.1.2.3–4
EPA ERLN Laboratory Requirements 3.2
EPA ERLN Laboratory Requirements 4.3.4
EPA ERLN Laboratory Requirements 4.8.1–4
EPA ERLN Laboratory Requirements 4.11.16
E.U. Commission Reg. No. 852/2004 Annex I, Section II.4.i
E.U. Commission Reg. No. 852/2004 Annex I, Section III.8.d
E.U. Commission Reg. No. 852/2004 Annex I, Section III.9.c
IFS Food 7, Part 2, 4.18.3
IFS PACsecure 2, Part 2, 4.18.3
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6
SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6
USDA Data and Instrumentation for PDP 5.4.2
USDA Data and Instrumentation for PDP 8.1.3
WHO Technical Report Series, #986, Annex 2, 15.8
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3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
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| WADA International Standard for Laboratories (ISL) 1.2
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3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.
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