Difference between revisions of "User:Shawndouglas/sandbox/sublevel13"

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[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 211.60 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 211.60 (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/21/225.30 21 CFR Part 225.30 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.60 21 CFR Part 211.606.60]<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 211.820.70 (g)]<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 211.820.72]<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/42/493.1252 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.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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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]
[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.
   | 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.
|-
  | 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/212.160 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.
|-
  | 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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Revision as of 17:53, 14 September 2019

Sandbox begins below

10. Instrument and Equipment Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-3-1 10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.
ASTM E1578-18 E-3-2 10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.
ASTM E1578-18 E-3-3 10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
ASTM E1578-18 E-3-4 10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
ASTM E1578-18 E-3-5 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.
ASTM E1578-18 E-3-6 10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.

21 CFR Part 211.67–68
21 CFR Part 211.160 (b-4)
21 CFR Part 211.30 (b)
21 CFR Part 211.60 (e)
21 CFR Part 225.30 (b-4)
21 CFR Part 606.60
21 CFR Part 820.70 (g)
21 CFR Part 820.72
42 CFR Part 493.1252 (b-3)
42 CFR Part 493.1255
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
AAVLD Requirements for an AVMDL Sec. 5.5
ABFT Accreditation Manual Sec. E-20
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1
AIHA-LAP Policies 2018 2C.3.7–2C.3.10
ASTM E1578-18 E-3-7
EPA 815-R-05-004 Chap. IV, Sec. 7
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
ISO 15189:2012 5.3.1.4
ISO/IEC 17025:2017 6.4.7
ISO/IEC 17025:2017 6.4.8
USDA Administrative Procedures for the PDP 5.2.4
USDA Data and Instrumentation for PDP 5.2
USDA Data and Instrumentation for PDP 6
WHO Technical Report Series, #986, Annex 2, 13.5
WHO Technical Report Series, #986, Annex 2, 16.23

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.

21 CFR Part 225.30 (b-4)
AAVLD Requirements for an AVMDL Sec. 5.5.9
ASTM E1578-18 E-3-8
WHO Technical Report Series, #986, Annex 2, 16.23

10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.

21 CFR Part 211.160 (b-4)
ABFT Accreditation Manual Sec. E-21
ASTM E1578-18 E-3-9
ISO 15189:2012 5.3.1.5
ISO/IEC 17025:2017 6.4.9
WHO Technical Report Series, #986, Annex 2, 13.10

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.

21 CFR Part 820.72 (b-2)
ASTM E1578-18 E-3-10
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
ISO/IEC 17025:2017 6.4.8
WHO Technical Report Series, #986, Annex 2, 16.23

10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.