Difference between revisions of "Template:LIMSpec/Results review and verification"
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[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-1]<br /> | ||
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4] | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]<br /> | ||
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1] | |||
| style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded. | | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded. | ||
|- | |- | ||
| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-2]<br /> | ||
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 1.2] | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<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;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests. | | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests. | ||
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[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | ||
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-3]<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 5.4.1.1]<br /> | [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br /> | ||
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> | ||
[https:// | [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br /> | ||
[https://extranet.who.int/ | [https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<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 4.13.2.3)]<br /> | |||
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br /> | |||
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<br /> | |||
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12] | |||
| style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results. | | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results. | ||
|- | |- | ||
| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (c)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.110]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | ||
[ | [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br /> | ||
[[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies | [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br /> | ||
[ | [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<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 G15.1]<br /> | ||
[https://www.astm.org/ | [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3]<br /> | ||
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> | |||
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5]<br /> | |||
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br /> | |||
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br /> | ||
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[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ||
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.6.4]<br /> | |||
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.4]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br /> | |||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br /> | |||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(3)]<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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]<br /> | |||
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.1]<br /> | |||
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1] | |||
| style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. | | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. | ||
|- | |- | ||
| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br /> | ||
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br /> | |||
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.5]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.6.4]<br /> | ||
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.4]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br /> | |||
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1] | |||
| style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. | | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. | ||
|- | |- | ||
| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.astm.org/ | [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-6]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] | ||
| style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. | | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. | ||
|- | |||
| style="padding:5px; width:500px;" |[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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 4.0]<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;" |'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards. | |||
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|} | |} | ||
|} | |} |