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| Regulation, Specification, or Guidance
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Requirement
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| ▪ ASTM E1578-18 C-6-1
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6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
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▪ EPA ERLN Laboratory Requirements 3.4
▪ EPA ERLN Laboratory Requirements 4.1.4
▪ EPA ERLN Laboratory Requirements 4.12–15
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6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.
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▪ 42 CFR Part 493.1291 (g) and (h)
▪ ACMG Technical Standards for Clinical Genetics Laboratories F7.2
▪ ASTM E1578-18 C-6-2
▪ CLSI QMS22 2.1.2.1
▪ EPA ERLN Laboratory Requirements 4.11.4
▪ EPA QA/G-5 2.4.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
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6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.
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| ▪ ABFT Accreditation Manual Sec. G-2
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6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.
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▪ 7 CFR Part 91.25
▪ 21 CFR Part 1.1152 (d)
▪ 40 CFR Part 141.33
▪ 42 CFR Part 493.1291 (c–e)
▪ AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
▪ AAVLD Requirements for an AVMDL Sec. 5.4.2.1
▪ AAVLD Requirements for an AVMDL Sec. 5.10.2–5
▪ AIHA-LAP Policies 2022 2A.7.8.1
▪ ABFT Accreditation Manual Sec. E-12 and -32
▪ ASTM E1578-18 C-6-3
▪ EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8
▪ EPA 815-R-05-004 Chap. VI, Sec. 8
▪ ISO 15189:2012 4.5.2
▪ ISO 15189:2012 5.8.3
▪ ISO/IEC 17025:2017 7.5.1
▪ ISO/IEC 17025:2017 7.8.1.1
▪ ISO/IEC 17025:2017 7.8.2.1
▪ ISO/IEC 17025:2017 7.8.3.1
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d
▪ WHO Technical Report Series, #986, Annex 2, 15.43
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6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.
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▪ 7 CFR Part 91.26–27
▪ 21 CFR Part 1.1152 (d)
▪ ASTM E1578-18 C-6-4
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6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
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▪ A2LA C211 5.10
▪ ASTM E1578-18 C-6-5
▪ BRC GSFS, Issue 8, 5.6.1.2
▪ BRC GSFS, Issue 8, 9.3.5
▪ CLSI QMS22 2.2.3
▪ ISO 15189:2012 5.8.1
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)
▪ USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3
▪ WADA International Standard for Laboratories (ISL) 5.3.8.4
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6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
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▪ 7 CFR Part 331.5
▪ 9 CFR Part 121.5–6
▪ 21 CFR Part 1.1110
▪ 21 CFR Part 1.1152 (a–b)
▪ 21 CFR Part 58.185
▪ 21 CFR Part 312.64
▪ 21 CFR Part 812.150
▪ 40 CFR Part 141.31
▪ 40 CFR Part 141.721
▪ 40 CFR Part 370 Subpart C
▪ 40 CFR Part 372 Subpart B
▪ 40 CFR Part 704
▪ 40 CFR Part 717 Subpart A
▪ 40 CFR Part 720.40
▪ 42 CFR Part 73.5–6
▪ 42 CFR Part 493.43 (d)
▪ ABFT Accreditation Manual Sec. E-7
▪ ACMG Technical Standards for Clinical Genetics Laboratories C13.3
▪ ACMG Technical Standards for Clinical Genetics Laboratories E8
▪ ACMG Technical Standards for Clinical Genetics Laboratories G17.1
▪ ASTM E1578-18 C-6-7
▪ CAP Laboratory Accreditation Manual
▪ CJIS Security Policy 5.3.1
▪ EPA ERLN Laboratory Requirements 4.12–15
▪ EPA QA/G-5 2.3.2
▪ IFS Food 7, Part 4, 2.x
▪ IFS PACsecure 2, Part 4, 1.x
▪ NIST 800-53, Rev. 5, IR-6 and IR-6(1)
▪ OECD GLP Principles 9.1
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (throughout)
▪ USDA Administrative Procedures for the PDP (throughout)
▪ WADA International Standard for Laboratories (ISL) 5.3.8.4
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6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
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▪ 7 CFR Part 91.28
▪ 21 CFR Part 1.1154 (c)
▪ 21 CFR Part 58 Sec. 58.185 (c)
▪ A2LA C211 5.10.9
▪ AAVLD Requirements for an AVMDL Sec. 5.10.9–10
▪ CLSI QMS22 2.2.3.4
▪ ICH GCP 4.9.3
▪ ISO/IEC 17025:2017 7.8.8
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ OECD GLP Principles 9.1
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)
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6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
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| ▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
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6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.
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| ▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
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6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.
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