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Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-12-1 APHL 2019 LIS Project Management Guidebook 26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems. APHL 2019 LIS Project Management Guidebook ASTM E1578-18 E-12-2 APHL 2019 LIS Project Management Guidebook 26.2 The system should be capable of sending samples and test orders to instrument data systems. ASTM E1578-18 E-12-3 APHL 2019 LIS Project Management Guidebook CLSI QMS22 2.2.2.5 EPA ERLN Laboratory Requirements 4.9.16 26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability. ASTM E1578-18 E-12-4 APHL 2019 LIS Project Management Guidebook 26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.105 (a) ASTM E1578-18 E-13-1 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. ASTM E1578-18 E-13-2 27.2 The system should accurately communicate overall system status changes to external systems. 21 CFR Part 11.10 (c) 21 CFR Part 58.190 ABFT Accreditation Manual C-15 https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf 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 OECD GLP Principles 3.4 OECD GLP Principles 10 USDA Administrative Procedures for the PDP 5.5 27.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive. 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 27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate. ASTM E1578-18 E-13-5 27.5 The system should feature a reliable, effective, and supported data storage system. ASTM E1578-18 C-6-6 ASTM E1578-18 E-13-6 CLSI QMS22 2.2.3.3 27.6 The system should be able to interface directly with a third-party reporting tool. ASTM E1578-18 E-13-7 27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards. ASTM E1578-18 E-13-8 27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed. ASTM E1578-18 E-13-9 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. ASTM E1578-18 E-13-10 27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data. 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 CAP Laboratory Accreditation Manual CLSI QMS22 2.4.2 CLSI QMS22 2.8.5 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 WHO Technical Report Series, #986, Annex 2, 15.9 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 from manipulation and loss. ASTM E1578-18 E-13-12 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. ASTM E1578-18 E-13-13 27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage. ASTM E1578-18 E-13-14 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. ASTM E1578-18 E-13-15 APHL 2019 LIS Project Management Guidebook E.U. Annex 11-5 ISO 15189:2012 5.10.3 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. ASTM E1578-18 E-13-16 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. ASTM E1578-18 E-13-17 27.17 The system should be able to interface with an external enterprise resource planning system. ASTM E1578-18 E-13-18 27.18 The system should be capable of interfacing with enterprise middleware.

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.25 (c) ACMG Technical Standards for Clinical Genetics Laboratories B2 ASTM E1578-18 E-14-1 28.1 The system should be able to accurately gauge and report test-based work capacity or throughput. ASTM E1578-18 E-14-2 28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks. ASTM E1578-18 E-14-3 28.3 The system should provide a means for tasks to be scheduled and allocated against available resources. 42 CFR Part 493.1274 (d) 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.

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-15-1 29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel. ASTM E1578-18 E-15-2 FDA Hazard Analysis Critical Control Point Principle 1 29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points. 21 CFR Part 211.42 (b) ASTM E1578-18 E-15-3 FDA Hazard Analysis Critical Control Point Principle 1 29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-16-1 30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant. ASTM E1578-18 E-16-2 30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets. ASTM E1578-18 E-16-3 30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions. ASTM E1578-18 E-16-4 30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input. ASTM E1578-18 E-16-5 NIST 800-53, Rev. 4, MA-6(2) 30.5 The system should support predictive maintenance routines for laboratory instruments and equipment. ASTM E1578-18 E-16-6 30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI. ASTM E1578-18 E-16-7 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. ASTM E1578-18 E-16-8 CLSI QMS22 2.1.2.1 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 4, SI-4(5) and SI-4(7) 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. 7 CFR Part 331.11 7 CFR Part 331.17 9 CFR Part 121.11 9 CFR Part 121.17 21 CFR Part 211.28 21 CFR Part 211.46 21 CFR Part 312.58 (b) 21 CFR Part 312.69 42 CFR Part 73.11 42 CFR Part 73.17 45 CFR Part 164.310 A2LA C211 5.3.4 A2LA C211 5.4.7.2 A2LA C223 5.3 AAVLD Requirements for an AVMDL Sec. 5.3.1–2 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1 ASTM E1492-11 4.1.8 ASTM E1492-11 4.4.2 ASTM E1578-18 E-16-9 CJIS Security Policy 5.9.1.6 CLSI QMS22 2.4.2 EPA ERLN Laboratory Requirements 4.1.13 EPA ERLN Laboratory Requirements 4.9.6 ISO 15189:2012 5.10.3 ISO/IEC 17025:2017 6.3.3 ISO/IEC 17025:2017 6.3.4 NIST 800-53, Rev. 4, MP-2 NIST 800-53, Rev. 4, PE-6(1) USDA Administrative Procedures for the PDP 5.2.1 USDA Sample Processing and Analysis Procedures for PDP 5.2 WHO Technical Report Series, #986, Annex 2, 9.5 WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18 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. 42 CFR Part 493.1252 ASTM E1578-18 E-16-10 ISO 15189:2012 5.10.3 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. 7 CFR Part 331.11 7 CFR Part 331.17 9 CFR Part 121.11 9 CFR Part 121.17 21 CFR Part 820.70 (c) 42 CFR Part 73.11 42 CFR Part 73.17 42 CFR Part 493.1252 42 CFR Part 493.1278 A2LA C211 5.3 A2LA C223 5.3 ACMG Technical Standards for Clinical Genetics Laboratories C1.2 AAVLD Requirements for an AVMDL Sec. 5.3.1–2 ABFT Accreditation Manual Sec. E-22 ASTM E1578-18 E-16-11 CAP Laboratory Accreditation Manual CLSI QMS22 2.2.3.5 ISO 15189:2012 5.2.6 ISO 15189:2012 5.10.3 ISO/IEC 17025:2017 6.3.3 ISO/IEC 17025:2017 6.3.4 ISO/IEC 17025:2017 7.4.4 OECD GLP Principles 10 USDA Sample Processing and Analysis Procedures for PDP 5.2 WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16 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.