Difference between revisions of "Template:LIMSpec/Reporting"

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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-1]
   | style="background-color:white;" |'''6.1''' The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
   | style="background-color:white;" |'''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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  |-  
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   | style="background-color:white;" |'''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.
   | style="background-color:white;" |'''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.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.2]
   | style="padding:5px; width:500px;" |
   | style="background-color:white;" |'''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.
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories F7.2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.2]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
   | style="background-color:white;" |'''6.3''' The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-2]
   | style="padding:5px; width:500px;" |[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-2]
   | style="background-color:white;" |'''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.  
   | style="background-color:white;" |'''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.  
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/91.25 7 CFR Part 91.25]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br />
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[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.1]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.8.1]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-3]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
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[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43]
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43]
   | style="background-color:white;" |'''6.5''' The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
   | style="background-color:white;" |'''6.5''' The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-4]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/7/91.26 7 CFR Part 91.26–27]<br />[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-4]
   | style="background-color:white;" |'''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.
   | style="background-color:white;" |'''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.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]
   | style="padding:5px; width:500px;" |
   | style="background-color:white;" |'''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.
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-5]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)]<br />
[https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4]
   | style="background-color:white;" |'''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, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br />
[https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br />
[https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br />
[https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1110]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (a–b)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br />
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br />
[https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br />
[https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br />
[https://www.law.cornell.edu/cfr/text/21/812.150 21 CFR Part 812.150]<br />
[https://www.law.cornell.edu/cfr/text/21/812.150 21 CFR Part 812.150]<br />
[https://www.law.cornell.edu/cfr/text/21/812.200 21 CFR Part 812.200]<br />
[https://www.law.cornell.edu/cfr/text/40/141.31 40 CFR Part 141.31]<br />
[https://www.law.cornell.edu/cfr/text/40/141.31 40 CFR Part 141.31]<br />
[https://www.law.cornell.edu/cfr/text/40/141.721 40 CFR Part 141.721]<br />
[https://www.law.cornell.edu/cfr/text/40/141.721 40 CFR Part 141.721]<br />
Line 62: Line 84:
[https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br />
[https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-7]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C13.3]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories E8]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G17.1]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-7]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 4, 2.x]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 4, 1.x]<br />
   | style="background-color:white;" |'''6.8''' The system should, in addition to standard reports, provide the means for custom 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.
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-6 and IR-6(1)]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4]
   | style="background-color:white;" |'''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, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/91.28 7 CFR Part 91.28]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1154 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10.9]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.4]<br />
[https://ichgcp.net/ ICH GCP 4.9.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)]
   | style="background-color:white;" |'''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.
   | style="background-color:white;" |'''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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Latest revision as of 21:45, 22 June 2023

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-6-1 6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
EPA ERLN Laboratory Requirements 3.4
EPA ERLN Laboratory Requirements 4.1.4
EPA ERLN Laboratory Requirements 4.12–15
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.

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

6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.
ABFT Accreditation Manual Sec. G-2 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.

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

6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
7 CFR Part 91.26–27
21 CFR Part 1.1152 (d)
ASTM E1578-18 C-6-4
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.

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

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, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.

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

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, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

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)

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.