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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==10. Instrument and Equipment Management==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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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
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-1]
| |
| | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-2]
| |
| | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-3]
| |
| | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-4]
| |
| | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-5]
| |
| | style="background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-6]
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| | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.60 21 CFR Part 606.60]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br />
| |
| [http://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 5.6.1.1]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-7]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.7''' The system shall allow the configuration of calibration and maintenance frequency and time frames, with available intervals of days, weeks, months, and years.
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| |-
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-8]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-9]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
| |
| | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-10]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-1)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7]
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6.1]<br />
| |
| | style="background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-11]
| |
| | style="background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating Instrument event dates.
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| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.4–5]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-12]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.2]
| |
| | style="background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-13]
| |
| | style="background-color:white;" |'''10.13''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/58.63 21 CFR Part 58.63]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.182 21 CFR Part 211.182]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1254 42 CFR Part 493.1254]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-14]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.46]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
| |
| | style="background-color:white;" |'''10.14''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
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| |-
| |
| |}
| |
| |}
| |
| | |
| ==11. Batch and Lot 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/21/58.105 21 CFR Part 58.105 (a)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
| |
| | style="background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-2]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
| |
| | style="background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-3]
| |
| | style="background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-4-4]
| |
| | style="background-color:white;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15]
| |
| | style="background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.
| |
| |-
| |
| |}
| |
| |}
| |
