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26. Systems Integration

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.105 (a) ASTM E1578-18 E-13-1 26.1 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 26.2 The system should accurately communicate status changes to external systems. 21 CFR Part 11.10 (c) 21 CFR Part 58.190 ABFT Accreditation Manual C-15 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 26.3 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 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 26.4 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 26.5 The system should feature a reliable, effective, and supported data storage system. ASTM E1578-18 C-6-6 ASTM E1578-18 E-13-6 26.6 The system should be able to interface directly with a third-party reporting tool. ASTM E1578-18 E-13-7 26.7 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 26.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed. ASTM E1578-18 E-13-9 26.9 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 26.10 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 AAVLD Requirements for an AVMDL Sec. 4.10.1.4 ASTM E1578-18 E-13-11 E.U. Annex 11-7.2 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. Commission Directive 2003/94/EC Article 9.2 ISO 15189:2012 5.10.3 ISO/IEC 17025:2017 8.4.2 WHO Technical Report Series, #986, Annex 2, 15.9 26.11 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 26.12 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 26.13 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 26.14 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 E.U. Annex 11-5 ISO 15189:2012 5.10.3 26.15 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 26.16 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 26.17 The system should be able to interface with an external enterprise resource planning system. ASTM E1578-18 E-13-18 26.18 The system should be capable of interfacing with enterprise middleware.

27. Laboratory Scheduling and Capacity Planning

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.25 (c) ASTM E1578-18 E-14-1 27.1 The system should be able to accurately gauge and report test-based work capacity or throughput. ASTM E1578-18 E-14-2 27.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks. ASTM E1578-18 E-14-3 27.3 The system should provide a means for tasks to be scheduled and allocated against available resources. 42 CFR Part 493.1274 (d) 27.4 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.

28. Lean Laboratory and Continuous Improvement

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-15-1 28.1 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 28.2 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 28.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.