Difference between revisions of "User:Shawndouglas/sandbox/sublevel15"

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==Sandbox begins below==
==Sandbox begins below==


==10. Inventory Management==
==15. Inventory Management==
{|  
{|  
  | STYLE="vertical-align:top;"|
  | STYLE="vertical-align:top;"|
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[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-7]
   | style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.
   | style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.
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[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-8]
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-8]
   | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.
   | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.
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==16. Investigation Management==
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)]
  | style="background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)]
  | style="background-color:white;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111]<br />
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
  | style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
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  |-  
|}
|}
|}
|}

Revision as of 20:34, 14 September 2019

This is sublevel15 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

15. Inventory Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-8-1 15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
21 CFR Part 212.60 (d)
ASTM E1578-18 E-8-2 		15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.

21 CFR Part 211.84
21 CFR Part 211.101
21 CFR Part 212.60 (d)
21 CFR Part 226.80
21 CFR Part 606.120 (b)
29 CFR Part 1910.1030 (g)
29 CFR Part 1910.1096 (e-6)
29 CFR Part 1910.1200 (f-6) and (f-10)
ASTM E1578-18 E-8-3
WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41
WHO Technical Report Series, #986, Annex 2, 15.10–12

15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.

21 CFR Part 212.40 (c)
21 CFR Part 820.50
ASTM E1578-18 E-8-4
USDA Administrative Procedures for the PDP 7.1
WHO Technical Report Series, #986, Annex 2, 14.8

15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.

21 CFR Part 211.196
21 CFR Part 212.90
21 CFR Part 225.110
21 CFR Part 606.165
29 CFR Part 1910.1450 Appendix A (I) ASTM E1578-18 E-8-5

 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.

21 CFR Part 211.82 (b)
21 CFR Part 211.84 (a)
21 CFR Part 211.89
21 CFR Part 211.110 (d)
21 CFR Part 211.142 (a)
21 CFR Part 212.40 (c)
ASTM E1578-18 E-8-6
WHO Technical Report Series, #986, Annex 2, 12.18

15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.

21 CFR Part 211.89
21 CFR Part 211.110 (d)
42 CFR Part 493.1252 (d)
ASTM E1578-18 E-8-7

15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.

21 CFR Part 211.89
ASTM E1578-18 E-8-8

15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.

16. Investigation Management

Regulation, Specification, or Guidance Requirement
21 CFR Part 312.62 (b)
21 CFR Part 812.140 (a-3) 		16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.

21 CFR Part 312.57 (a)
21 CFR Part 312.62 (a)
21 CFR Part 606.165
21 CFR Part 812.140 (a-2) and (b-2)

16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.

21 CFR Part 58.81 (a)
21 CFR Part 211.100
21 CFR Part 211.111
21 CFR Part 211.192
21 CFR Part 211.194
21 CFR Part 606.171
42 CFR Part 493.1253 (b-2)
ABFT Accreditation Manual C-16
ABFT Accreditation Manual F-2
ABFT Accreditation Manual J-3
ASTM E1578-18 E-9-1
EPA ERLN Laboratory Requirements 3.3
EPA QA/G-5 2.2.4
ISO/IEC 17025:2017 7.2.1.7
ISO/IEC 17025:2017 7.2.2.1
ISO/IEC 17025:2017 7.10.2
ISO/IEC 17025:2017 8.7.1
OECD GLP Principles 7.3
USDA Administrative Procedures for the PDP 8.2.2
WHO Technical Report Series, #986, Annex 2, 16.3

16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
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