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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==15. Inventory Management==
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| {|
| |
| | STYLE="vertical-align:top;"|
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| {| 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.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-1]
| |
| | style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-2]
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| | style="background-color:white;" |'''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.
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| |-
| |
| | style="padding:5px; width:500px;" |
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| [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 />
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| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
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| [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
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| [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 (e-6)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-3]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12]
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| | style="background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.
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| |-
| |
| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8]
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| | style="background-color:white;" |'''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.
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| |-
| |
| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.196 21 CFR Part 211.196]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br />
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| [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-5]<br />
| |
| | style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.82 21 CFR Part 211.82 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-6]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.18]
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| | style="background-color:white;" |'''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.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [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/42/493.1252 42 CFR Part 493.1252 (d)]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-7]
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| | 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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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [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]
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| | 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.
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| |-
| |
| | 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.
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| |-
| |
| | 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 />
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| [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.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-2]
| |
| | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-3]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]
| |
| | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-4]<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 13]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| |
| | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-5]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<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 13]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| |
| | style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-6]
| |
| | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
| |
| |-
| |
| |}
| |
| |}
| |
