Difference between revisions of "Template:LIMSpec/Sample 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/e1578-18.html ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14] | | style="padding:5px; width:500px;" | | ||
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-1]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]<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, 2.6.2]<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, 2.6.2]<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, 2.6.2] | |||
| style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents. | | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents. | ||
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| style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status. | | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status. | ||
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| style="padding:5px; width:500px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<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 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10] | | style="padding:5px; width:500px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br /> | |||
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<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 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10] | |||
| style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents. | | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents. | ||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1138]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1153 (c)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.315]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br /> | [https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br /> | ||
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[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.2]<br /> | |||
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br /> | [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br /> | ||
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[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25] | [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25] | ||
| style="background-color:white;" |'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | | style="background-color:white;" |'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | ||
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| style="padding:5px; width:500px;" |[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products FDA Q1A(R2)] | |||
| style="background-color:white; vertical-align: text-top;" |'''2.12''' The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study. | |||
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