View source for LIMSpec for Cannabis Testing/Security and integrity of systems and operations/System validation and commission

{| 
 | 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:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-1]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(3)]
  | style="background-color:white; vertical-align: text-top;" |'''24.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-2]<br />▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(2)]
  | style="background-color:white; vertical-align: text-top;" |'''24.2''' The vendor should be willing to provide access to source code through a suitable escrow.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-3]
  | style="background-color:white; vertical-align: text-top;"  |'''24.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [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://www.astm.org/e1578-18.html ASTM E1578-18 S-2-4]<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 7.11.5]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5]
  | style="background-color:white; vertical-align: text-top;"  |'''24.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (i)]<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://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://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 2.5]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-11]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<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 7.11.2]<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 4.1]<br />
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)]<br />
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 10.2]
  | style="background-color:white; vertical-align: text-top;"  |'''24.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-2]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.5]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-4]<br />
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 10.3–7]
  | style="background-color:white; vertical-align: text-top;"  |'''24.6''' The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
 |- 
|}
|}