Systems integration performance, verifying

In the pre-operational tests, components and systems are tested. Integrated tests of several interacting systems are performed too. Therefore, the functional consistency of the systems to the design is verified, as well as the absence of vibrations, normal operation in general and the normal expansion and contraction of systems while they heat up and cool down, etc. 

The six-years long project of the SMART pilot plant development was launched in July 2002. The objectives of this project are to verify the integral performance of the SMART system and nuclear desalination technologies and to confirm their commercial viability through the construction and operation of a 1/5 scale pilot plant, SMART-P. The SMART-P project is carried out by consortium of governmental organizations and domestic nuclear industries, with strong support from the nuclear community... 

In addition to testing the system components, a test of software functionality would be performed to test the system software operation and electronic records and electronic signatures (ERES) compliance (security, data integrity, data backup, and archive). In order to test the software functionality, a predetermined set of instructions can be entered step by step into the system. The system responses are then compared to the expected outcomes of the instruction and any problems with the execution are determined. Some vendors will provide a standard set of data which can be processed by the system to verify the data-handling capability of the system. 

Qualification is the process of demonstrating whether a computer system and its associated controlled process/operation, procedural controls, and documentation are capable of fulfilling the specified requirements. Sidebar 10-11 depicts the context of the qualification activities and the computer systems validation process. The physical components of the systems are reviewed and its specific elements, subunits, and parameters are documented. A qualification also serves to verify and document the acceptability of the design, implementation, integration, and installation of the computer system components. The execution of the qualification is the mechanism by which documented evidence is created that verifies that the computer system performs according to its predetermined specification. 

The final integrated hardware/software system must achieve a full IQ to verify that the predetermined hardware and software configuration specifications are satisfied. Be sure to verify that the software version installed on the final system is the same as the one used for OQ testing on the pilot system. If not, there must be formal change control documentation in place that verifies that the validated status of the software has not been affected. There must also be some operational testing done on the final system. If the validation plan has identified the need for IQ, OQ, and PQ, it would be reasonable to perform the OQ on the pilot system and PQ on the final system. If only IQ... 

Based on the quantity of data and the complexity of the process, an enterprise operational informatics system must be robust and scalable. It should also integrate with analytical instrumentation such as high performance liquid chromatography (HPLC) MS to verify compound identity. A recent review of HTS informatics provides a compact overview of the key informatics elements of HTS operations and data handling (Ling, 2008). 

For equipment or systems controlled or monitored by a computer-related system, the functional testing cycle approach to computer validation is included and performed as part of the Operational Qualification. Functional testing verifies that the integrated hardware and software program perform in accordance with the functional specifications developed during the requirements phase. 

The automatic filter integrity tester will be operationally qualified, and all test parameters and acceptable test results will be verified in the Operational and Performance Qualifications of the equipment, for example, the Sterilizing Filter and the Media Preparation System. 

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