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| Regulation, Specification, or Guidance
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Requirement
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▪ ASTM E1578-18 S-2-1
▪ CJIS Security Policy Appendix G.8
▪ NIST 800-53, Rev. 5, SA-4(3)
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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.
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▪ ASTM E1578-18 S-2-2
▪ NIST 800-53, Rev. 5, SA-4(2)
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24.2 The vendor should be willing to provide access to source code through a suitable escrow.
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| ▪ ASTM E1578-18 S-2-3
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24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.
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▪ A2LA C211 5.4.7.2
▪ ASTM E1578-18 S-2-4
▪ ISO 15189:2012 5.10.3
▪ ISO/IEC 17025:2017 7.11.5
▪ NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5
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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.
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▪ 21 CFR Part 11.10 (a)
▪ 21 CFR Part 820.70 (i)
▪ A2LA C211 5.4.7.2
▪ ACMG Technical Standards for Clinical Genetics Laboratories C5.7
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.5
▪ EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
▪ E.U. Annex 11-11
▪ EPA 815-R-05-004 Chap. IV, Sec. 8.6
▪ EPA 815-R-05-004 Chap. VI, Sec. 8.6
▪ E.U. Commission Directive 2003/94/EC Article 9.2
▪ ISO 15189:2012 5.10.3
▪ ISO/IEC 17025:2017 7.11.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ OECD GLP Principles 4.1
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)
▪ WHO Technical Report Series, #996, Annex 5, 10.2
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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.
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▪ ASTM E1578-18 S-2-2
▪ CLSI QMS22 2.5
▪ E.U. Annex 11-4
▪ WHO Technical Report Series, #996, Annex 5, 10.3–7
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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.
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