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| Regulation, Specification, or Guidance
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Requirement
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▪ 21 CFR Part 211.105 (a)
▪ ASTM E1578-18 E-13-1
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18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.
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| ▪ ASTM E1578-18 E-13-2
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18.2 The system should accurately communicate overall system status changes to external systems.
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▪ 21 CFR Part 11.10 (c)
▪ 21 CFR Part 58.190
▪ ABFT Accreditation Manual C-15
▪ APHL 2019 LIS Project Management Guidebook
▪ ASTM E1578-18 E-13-3
▪ EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14
▪ ISO/IEC 17025:2017 8.4.2
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ OECD GLP Principles 3.4
▪ OECD GLP Principles 10
▪ USDA Administrative Procedures for the PDP 5.5
▪ WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1
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18.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
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▪ 21 CFR Part 11.10 (c)
▪ 21 CFR Part 58.51
▪ 21 CFR Part 58.190
▪ ABFT Accreditation Manual C-15
▪ ASTM E1578-18 E-13-4
▪ CAP Laboratory Accreditation Manual
▪ EPA ERLN Laboratory Requirements 4.9.5
▪ E.U. Annex 11-17
▪ ISO/IEC 17025:2017 8.4.2
▪ OECD GLP Principles 3.4
▪ OECD GLP Principles 10
▪ USDA Administrative Procedures for the PDP 5.2.1
▪ USDA Administrative Procedures for the PDP 5.5
▪ WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1
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18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
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| ▪ ASTM E1578-18 E-13-5
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18.5 The system should feature a reliable, effective, and supported data storage system.
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▪ 21 CFR Part 1.1110
▪ 21 CFR Part 1.1152 (a–b)
▪ ASTM E1578-18 C-6-6
▪ ASTM E1578-18 E-13-6
▪ CLSI QMS22 2.2.3.3
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ WADA International Standard for Laboratories (ISL) 5.2.3.5
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18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.
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| ▪ ASTM E1578-18 E-13-7
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18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
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| ▪ ASTM E1578-18 E-13-8
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18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.
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| ▪ ASTM E1578-18 E-13-9
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18.9 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.
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| ▪ ASTM E1578-18 E-13-10
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18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.
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▪ 21 CFR Part 11.10 (c)
▪ 21 CFR Part 211.68 (b)
▪ 21 CFR Part 820.180
▪ 45 CFR Part 164.308
▪ A2LA C211 4.13.1.4
▪ AAVLD Requirements for an AVMDL Sec. 4.10.1.4
▪ ACMG Technical Standards for Clinical Genetics Laboratories C5.7
▪ APHL 2019 LIS Project Management Guidebook
▪ ASTM E1578-18 E-13-11
▪ BRC GSFS, Issue 8, 3.2.1
▪ BRC GSFS, Issue 8, 3.3.1
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.4.2
▪ CLSI QMS22 2.8.5
▪ EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
▪ EPA 815-R-05-004 Chap. IV, Sec. 8
▪ EPA 815-R-05-004 Chap. VI, Sec. 7.6
▪ EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14
▪ EPA QA/G-5 2.1.9
▪ E.U. Annex 11-7.2
▪ E.U. Commission Directive 2003/94/EC Article 9.2
▪ ISO 15189:2012 5.10.3
▪ ISO/IEC 17025:2017 8.4.2
▪ NIST 800-53, Rev. 5, CP-9 and CP-10
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)
▪ WADA International Standard for Laboratories (ISL) 5.2.3.5
▪ WHO Technical Report Series, #986, Annex 2, 15.9
▪ WHO Technical Report Series, #996, Annex 5, Appendix 1
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18.11 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 from manipulation and loss.
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| ▪ ASTM E1578-18 E-13-12
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18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
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| ▪ ASTM E1578-18 E-13-13
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18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
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| ▪ ASTM E1578-18 E-13-14
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18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
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▪ ASTM E1578-18 E-13-15
▪ APHL 2019 LIS Project Management Guidebook
▪ E.U. Annex 11-5
▪ ISO 15189:2012 5.10.3
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18.15 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 among instruments and third-party systems like state- and locally mandated seed-to-sale systems.
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| ▪ ASTM E1578-18 E-13-16
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18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
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| ▪ ASTM E1578-18 E-13-17
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18.17 The system should be able to interface with an external enterprise resource planning system.
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| ▪ ASTM E1578-18 E-13-18
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18.18 The system should be capable of interfacing with enterprise middleware.
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