Difference between revisions of "Template:LIMSpec/Instrument and equipment management"

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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 E-3-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-1]
   | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
   | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-2]
   | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
   | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-3]
   | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
   | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-4]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-4]
   | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
   | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-5]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-5]
   | style="background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
   | style="background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-6]
   | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
   | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.40 (f)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
Line 37: Line 38:
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.2]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.5]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br />
[http://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 5.6.1.1]<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 C1.5]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<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 5.6.1.1]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-7]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-7]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<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 2.6.1]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.4.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-2 and MA-2(2)]<br />
[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.7.1]<br />
[https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.7]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2 and MA-2(2)]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
   | style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
   | style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-8]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-8]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.4.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.2]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
   | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
   | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-9]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.6]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-9]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.4.3]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4]<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 5.5.7)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
   | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
   | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.117]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-10]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-10]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-6(1)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
   | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
   | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
  |-  
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Line 86: Line 121:
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-1)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-1)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.6.2.1]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.6]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7]
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]
[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.7.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6.1]<br />
[https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.7]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2]<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 5.6.2.1 and 5.6.4.1)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6.1]
   | style="background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
   | style="background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-11]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-11]
   | style="background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating Instrument event dates.
   | style="background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating instrument event dates.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.40 (f)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.4 and 5.5.5]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.4–5]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.4–5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-12]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-12]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 6.4.x]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.4.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.7]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-8]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-8]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.2]
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6]<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 5.5)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.2]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 6.1]
   | style="background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
   | style="background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-13]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-13]
   | style="background-color:white;" |'''10.14''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
   | style="background-color:white;" |'''10.14''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
  |-  
  |-  
   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103]<br />
[https://www.law.cornell.edu/cfr/text/21/58.63 21 CFR Part 58.63]<br />
[https://www.law.cornell.edu/cfr/text/21/58.63 21 CFR Part 58.63]<br />
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.117]<br />
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
Line 126: Line 188:
[https://www.law.cornell.edu/cfr/text/42/493.1254 42 CFR Part 493.1254]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1254 42 CFR Part 493.1254]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.1]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.5.2]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10.4]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-14]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-14]<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 2.2.2.1]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.4.2]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4–5]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-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.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6]<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 5.5)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.46]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.46]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
   | style="background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
   | style="background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
  |-  
  |-  
|}
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Latest revision as of 21:28, 14 December 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-3-1 10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.
ASTM E1578-18 E-3-2 10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.
ASTM E1578-18 E-3-3 10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
ASTM E1578-18 E-3-4 10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
ASTM E1578-18 E-3-5 10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
ASTM E1578-18 E-3-6 10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.

21 CFR Part 110.40 (f)
21 CFR Part 211.67–68
21 CFR Part 211.160 (b-4)
21 CFR Part 212.30 (b)
21 CFR Part 212.60 (e)
21 CFR Part 225.30 (b-4)
21 CFR Part 606.60
21 CFR Part 820.70 (g)
21 CFR Part 820.72
42 CFR Part 493.1252 (b-3)
42 CFR Part 493.1255
A2LA C211 5.5.2
A2LA C223 5.5
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
AAVLD Requirements for an AVMDL Sec. 5.5
ABFT Accreditation Manual Sec. E-20
ACMG Technical Standards for Clinical Genetics Laboratories C1.5
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1
AIHA-LAP Policies 2022 2C.3.7–2C.3.10
ASTM E1578-18 E-3-7
BRC GSFS, Issue 8, 6.4.x
CAP Laboratory Accreditation Manual
CLSI QMS22 2.6.1
EPA 815-R-05-004 Chap. IV, Sec. 7
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19
IFS Food 7, Part 2, 5.4.2
IFS PACsecure 2, Part 2, 5.4.2
ISO 15189:2012 5.3.1.4
ISO/IEC 17025:2017 6.4.7
ISO/IEC 17025:2017 6.4.8
ISO/TS 22002-4:2013, 4.7.1
ISO/TS 22002-6:2016, 4.7
NIST 800-53, Rev. 5, MA-2 and MA-2(2)
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1
USDA Administrative Procedures for the PDP 5.2.4
USDA Data and Instrumentation for PDP 5.2
USDA Data and Instrumentation for PDP 6
WADA International Standard for Laboratories (ISL) 5.2.4
WHO Technical Report Series, #986, Annex 2, 13.5
WHO Technical Report Series, #986, Annex 2, 16.23

10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.

21 CFR Part 225.30 (b-4)
AAVLD Requirements for an AVMDL Sec. 5.5.9
ASTM E1578-18 E-3-8
BRC GSFS, Issue 8, 6.4.x
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
IFS Food 7, Part 2, 5.4.2
IFS PACsecure 2, Part 2, 5.4.2
WHO Technical Report Series, #986, Annex 2, 16.23

10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.

21 CFR Part 211.160 (b-4)
A2LA C211 5.5.7
A2LA C223 5.6
ABFT Accreditation Manual Sec. E-21
ASTM E1578-18 E-3-9
BRC GSFS, Issue 8, 6.4.x
CLSI QMS22 2.1.2.1
IFS Food 7, Part 2, 5.4.3
IFS PACsecure 2, Part 2, 5.4.3
ISO 15189:2012 5.3.1.5
ISO/IEC 17025:2017 6.4.4
ISO/IEC 17025:2017 6.4.9
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)
WHO Technical Report Series, #986, Annex 2, 13.10

10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.

21 CFR Part 111.117
21 CFR Part 820.72 (b-2)
ASTM E1578-18 E-3-10
BRC GSFS, Issue 8, 6.4.x
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
ISO/IEC 17025:2017 6.4.8
NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)
WHO Technical Report Series, #986, Annex 2, 16.23

10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.

21 CFR Part 820.72 (b-1)
42 CFR Part 493.1255
A2LA C211 5.6.2.1
A2LA C223 5.6
AAVLD Requirements for an AVMDL Sec. 5.6.1–2
AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3
BRC GSFS, Issue 8, 6.4.x
EPA 815-R-05-004 Chap. IV, Sec. 7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
ISO/IEC 17025:2017 6.4.13
ISO/IEC 17025:2017 6.5
ISO/TS 22002-4:2013, 4.7.1
ISO/TS 22002-6:2016, 4.7
OECD GLP Principles 4.2
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)
USDA Data and Instrumentation for PDP 6.1

10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
ASTM E1578-18 E-3-11 10.12 The system shall support the use of predefined intervals when calculating instrument event dates.

21 CFR Part 110.40 (f)
21 CFR Part 211.105 (b)
42 CFR Part 493.1255
A2LA C211 5.5.4 and 5.5.5
AAVLD Requirements for an AVMDL Sec. 5.5.4–5
ASTM E1578-18 E-3-12
BRC GSFS, Issue 8, 6.4.x
EPA 815-R-05-004 Chap. IV, Sec. 7
EPA QA/G-5 2.2.6–7
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1
IFS Food 7, Part 2, 5.4.1
IFS PACsecure 2, Part 2, 5.4.1
ISO 15189:2012 5.3.1.7
ISO/IEC 17025:2017 6.4.8
ISO/IEC 17025:2017 6.4.13
NIST 800-53, Rev. 5, CM-8
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)
USDA Administrative Procedures for the PDP 7.2
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j
WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4
WHO Technical Report Series, #961, Annex 13, 6.1

10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
ASTM E1578-18 E-3-13 10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.

10 CFR Part 20.2103
21 CFR Part 58.63
21 CFR Part 111.117
21 CFR Part 211.67–68
21 CFR Part 211.160 (b-4)
21 CFR Part 211.182
21 CFR Part 211.194 (d)
21 CFR Part 212.30 (b)
21 CFR Part 212.60 (e)
21 CFR Part 820.70 (g)
21 CFR Part 820.72
42 CFR Part 493.1254
42 CFR Part 493.1255
A2LA C211 4.13.2.1
A2LA C211 5.5.2
A2LA C211 5.10.4
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
AAVLD Requirements for an AVMDL Sec. 5.5
ABFT Accreditation Manual Sec. E-20 and -23
ABFT Accreditation Manual Sec. F-1 and I-1
AIHA-LAP Policies 2022 2C.3.7–2C.3.10
ASTM E1578-18 E-3-14
CAP Laboratory Accreditation Manual
CLSI QMS22 2.2.2.1
EPA 815-R-05-004 Chap. IV, Sec. 7
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19
IFS Food 7, Part 2, 5.4.2
IFS PACsecure 2, Part 2, 5.4.2
ISO 15189:2012 5.3.1.4
ISO/IEC 17025:2017 6.4.4–5
ISO/IEC 17025:2017 6.4.13
NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OECD GLP Principles 4.2
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1
SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1
SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1
SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)
USDA Administrative Procedures for the PDP 5.2.4
USDA Data and Instrumentation for PDP 5.4
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c
WADA International Standard for Laboratories (ISL) 5.2.4
WHO Technical Report Series, #986, Annex 2, 15.46
WHO Technical Report Series, #986, Annex 2, 16.23

10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.