View source for LIMSpec/Instrument and equipment management

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  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  | 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="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.
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  | 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.
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  | 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.
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  | 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.
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  | 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.
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  | 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/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
[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/21/606.60 21 CFR Part 606.60]<br />
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<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://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.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://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://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/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/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 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.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, 13.5]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
  | style="background-color:white;" |'''10.7''' 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;" |
[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.astm.org/e1578-18.html ASTM E1578-18 E-3-8]<br />
[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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<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://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/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.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.
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  | 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.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/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://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/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="padding:5px; width:500px;" |
[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.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.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3]<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://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/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://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="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="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/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.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://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/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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-8]<br />
[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="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="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/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/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.182 21 CFR Part 211.182]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<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.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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://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. F-1 and I-1]<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-3-14]<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://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://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/66912.html ISO/IEC 17025:2017 6.4.4–5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<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 Data and Instrumentation for PDP 5.4]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c]<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/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.
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