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 />

Revision as of 18:48, 1 December 2022

Regulation, Specification, or Guidance Requirement

ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14
SQF FSC 9, Food Manufacturing, Part B, 2.6.2
SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2

2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14
2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14
2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14
2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14
2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14
2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.
ASTM E1578-18 C-2-8
EPA ERLN Laboratory Requirements 3.2
ISO/IEC 17025:2017 7.4.2
2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 211.84
42 CFR Part 73.17
ASTM E1492-11 4.2.1
ASTM E1578-18 C-2-9
CAP Laboratory Accreditation Manual

2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.

21 CFR Part 1.1152 (d)
A2LA C211 5.4
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
ASTM E1578-18 C-2-10

2.10 The system shall be able to link test methods and specifications to standards and reagents.

21 CFR Part 1.1138
21 CFR Part 1.1150
21 CFR Part 1.1153 (c)
21 CFR Part 111.315
21 CFR Part 129.80 (g)
21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
A2LA C223 5.9
ACMG Technical Standards for Clinical Genetics Laboratories C6.2
ACMG Technical Standards for Clinical Genetics Laboratories C10–12
CAP Laboratory Accreditation Manual
ASTM E1578-18 C-2-11
EPA ERLN Laboratory Requirements 3.1.2.1
EPA ERLN Laboratory Requirements 4.3.2
EPA ERLN Laboratory Requirements 4.11.3.2
EPA QA/G-5 2.2.5
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
NYSDOH ELAP Medical Marijuana Microbiology Guidance
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)
USDA Administrative Procedures for the PDP 8.5
USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h
WADA International Standard for Laboratories (ISL) 5.3.7
WHO Technical Report Series, #961, Annex 13, 12.1
WHO Technical Report Series, #986, Annex 2, 17.7
WHO Technical Report Series, #986, Annex 2, 17.22–25

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.