Difference between revisions of "User:Shawndouglas/sandbox/sublevel24"

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| text      = This is sublevel24 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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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/e1578-18.html ASTM E1578-18 E-12-1]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 2.0]
  | style="background-color:white;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br />
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-2]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 2.0]
  | style="background-color:white;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-3]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 2.0]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.16]
  | style="background-color:white;" |'''26.3''' The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-4]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 2.0]
  | style="background-color:white;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.
|-
|}
|}


{|
==Sandbox begins below==
| 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/21/211.105 21 CFR Part 211.105 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-1]
  | style="background-color:white;" |'''27.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-2]
  | style="background-color:white;" |'''27.2''' The system should accurately communicate overall system status changes to external systems.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
  | style="background-color:white;" |'''27.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-4]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
  | style="background-color:white;" |'''27.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-5]
  | style="background-color:white;" |'''27.5''' The system should feature a reliable, effective, and supported data storage system.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-6]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.3]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
  | style="background-color:white;" |'''27.6''' The system should be able to interface directly with a third-party reporting tool.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-7]
  | style="background-color:white;" |'''27.7''' The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-8]
  | style="background-color:white;" |'''27.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-9]
  | style="background-color:white;" |'''27.9''' The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-10]
  | style="background-color:white;" |'''27.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.1.4]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C5.7]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-11]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.8.5]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-9 and CP-10]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
  | style="background-color:white;" |'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-12]
  | style="background-color:white;" |'''27.12''' The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-13]
  | style="background-color:white;" |'''27.13''' The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-14]
  | style="background-color:white;" |'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-15]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
  | style="background-color:white;" |'''27.15''' The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-16]
  | style="background-color:white;" |'''27.16''' The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-17]
  | style="background-color:white;" |'''27.17''' The system should be able to interface with an external enterprise resource planning system.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-18]
  | style="background-color:white;" |'''27.18''' The system should be capable of interfacing with enterprise middleware.
|-
|}
|}
 
{|
| 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/21/211.25 21 CFR Part 211.25 (c)]<br />[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B2]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-1]
  | style="background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-2]
  | style="background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-3]
  | style="background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]
  | style="background-color:white;" |'''28.4''' The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.
|-
|}
|}
 
{|
| 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.astm.org/e1578-18.html ASTM E1578-18 E-15-1]
  | style="background-color:white;" |'''29.1''' The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-15-2]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
  | style="background-color:white;" |'''29.2''' The system should provide a means to quickly visualize and assess workflow processes at strategic points.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.42 21 CFR Part 211.42 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-15-3]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
  | style="background-color:white;" |'''29.3''' The system should provide a means for mapping everyday workflow while identifying potential failure points.
|-
|}
|}
 
{|
| 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.astm.org/e1578-18.html ASTM E1578-18 E-16-1]
  | style="background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-2]
  | style="background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-3]
  | style="background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-4]
  | style="background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-5]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-6(2)]
  | style="background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-6]
  | style="background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-7]
  | style="background-color:white;" |'''30.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-8]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)]
  | style="background-color:white;" |'''30.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/211.28 21 CFR Part 211.28]<br />
[https://www.law.cornell.edu/cfr/text/21/211.46 21 CFR Part 211.46]<br />
[https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/312.69 21 CFR Part 312.69]<br />
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.3.4]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.7.2]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.3]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[https://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 5.3.4.1]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.8]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.4.2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-9]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MP-2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PE-6(1)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 9.5]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18]
  | style="background-color:white;" |'''30.9''' The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
|- 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-10]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
  | style="background-color:white;" |'''30.10''' The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.3]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.3]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C1.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-11]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.2.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16]
  | style="background-color:white;" |'''30.11''' The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.
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