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Requirement and response
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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.
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27.2 The system should accurately communicate status changes to external systems.
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27.3 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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27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
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27.5 The system should feature a reliable, effective, and supported data storage system.
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27.6 The system should be able to interface directly with a third-party reporting tool.
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27.7 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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27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.
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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.
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27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.
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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.
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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.
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27.13 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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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.
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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.
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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.
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27.17 The system should be able to interface with an external enterprise resource planning system.
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27.18 The system should be capable of interfacing with enterprise middleware.
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