Difference between revisions of "User:Shawndouglas/sandbox/sublevel8"

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==Sandbox begins below==
==Sandbox begins below==
==1.1 Vendor services==
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  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.1 '''Sample/Experiment Registration'''
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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.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-1]
  | style="background-color:white;" |The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
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  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />[https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br />[https://www.law.cornell.edu/cfr/text/21/606.140 21 CFR Part 606.140 (c)]<br />[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.1.6]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 15]<br />[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
  | style="background-color:white;" |The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
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Revision as of 15:44, 13 September 2019

Sandbox begins below

1.1 Vendor services

1.1 Sample/Experiment Registration
Regulation, Specification, or Guidance Requirement
42 CFR Part 493.1241
ASTM E1578-18 C-1-1
The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
21 CFR Part 58.105 (c)
21 CFR Part 211.84
21 CFR Part 211.101
21 CFR Part 226.80
21 CFR Part 606.120 (b)
21 CFR Part 606.121 (c–i)
21 CFR Part 606.140 (c)
29 CFR Part 1910.1030 (g)
29 CFR Part 1910.1096 (e1-6)

42 CFR Part 493.1232
ABFT Accreditation Manual Sec. D
ASTM E1492-11 4.1.1.6
ASTM E1578-18 C-1-2
EPA ERLN Laboratory Requirements 3.2.2
EPA QA/G-5 2.2.3
E.U. Commission Directive 2003/94/EC Article 15
OECD GLP Principles 6.1
USDA Sampling Procedures for PDP 6.4.1.2.6
WHO Technical Report Series, #986, Annex 2, 17.11

The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.