View source for LIMSpec for Cannabis Testing/Security and integrity of systems and operations/Cybersecurity

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1231 42 CFR Part 493.1231]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d-9)]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-4-1]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.4]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.8.2.1]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.10.1.2]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.6]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.2]<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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-17(2)]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4(6)]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SC-8 and SC-8(1)]
  | style="background-color:white; vertical-align: text-top;" |'''26.1''' The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1231 42 CFR Part 493.1231]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<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 C1.6]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-4-2]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.4]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.10.1.2]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.6]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-9(8)]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SC-13 and SC-28(1)]
  | style="background-color:white; vertical-align: text-top;" |'''26.2''' The system should support database encryption and be capable of recording the encryption status of the data contained within.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1231 42 CFR Part 493.1231]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.2.2.1]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2.2]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-3]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2, IA-2(1–4), and IA-8]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]
  | style="background-color:white; vertical-align: text-top;" |'''26.3''' The system should be able to support multifactor authentication.
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/45/170.202 45 CFR Part 170.202]<br />▪ [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (h)]
  | style="background-color:white; vertical-align: text-top;" |'''26.4''' The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-7]
  | style="background-color:white; vertical-align: text-top;" |'''26.5''' The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SC-15]
  | style="background-color:white; vertical-align: text-top;" |'''26.6''' The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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