Integration Test Specification

Once the software design specification is produced and approved it is possible to generate a software module integration test specification. It is advantageous to produce these documents in parallel so that software definition and testing correspond. 

To allow the pharmaceutical manufacturer to ensure the correctness and completeness of the software design through traceability to the FDS To provide input to the system integration test specification To ensure a structured approach to the presentation of information that can be carried forward into the software test specifications To ensure a structured approach to the presentation of information that can be carried forward, as applicable, into the software module design specifications produced later in the system design... 

Integration test specification—for testing the software module integration against the software design specification on suitable hardware. 

Integration tests are conducted to challenge the integration of new modules into the system. Table 31.14 provides the typical scope of the integration test specification. 

In general, in order to ensure testability, it is recommended that the application software integration test specifications are considered during the design and development phase. 

Application software architecture and subsystem integration test specification... 

Application program simulation and integration test specification (structure based testing)... 

Software and PE integration test specification to include but not be limited to System splitting to integration level Test case and test data Test types... 

There are advantages and disadvantages to each method. The integral method is easy to use and is recommended when testing specific mechanisms, or relatively simple rate expressions, or when the data are so scattered that we cannot reliably find the derivatives needed in the differential method. The differential method is useful in more complicated situations but requires more accurate or larger amounts of data. The integral method can only test this or that particular mechanism or rate form the differential method can be used to develop or build up a rate equation to fit the data. 

The integrity of the product container/closure is assessed by physical tests or microbiological challenge tests and long-term product sterility tests. These tests are specific for container size, fill volume, and closure type. All integrity tests are performed after sterilization and are defined in manufacturing site SOPs. 

Unlike sterilizing and virus removal filters, tangential flow filtration (TFF) filters are often reused. Flow and integrity tests are necessary to ensure the filter remains the same after usage and cleaning. Consistency of filtrate and retentate streams is validated using relevant validated assays that are specific for each process and product. 

Filters used for the prefiltration and final filtration should be maintained to operate to their design specifications. Deterioration of filters is caused by leakage and/or accumulation of particles. The former is tested by periodical integrity test (usually dioctylphthalate DOP test), and the latter is tested by the increase of air pressure differentials between the upstream and downstream sides of the fdter. 

Project Quality Plan Software Quality Assurance Program Functional Design Specification Hardware Design Specification Software Design Specification Software Module Design Specification Software Review Software Module Test Records Hardware Test Records Integration Test Records Instrument Spccs/Data Sheets Instrument Calibration Records Material Certificates... 

The software test strategy and detailed test scripts (protocol) are reviewed and approved by the Project Team. This review will verify that the test cases will stress the program interfaces, challenge the data boundaries and limits, and verily that the test cases are traceable to the appropriate clauses in the requirements specification deliverable. The review also verifies that the test cases adequately cover the risks identified in the Risk Analysis. The unit/ integration test results are documented by the programmer, and reviewed, approved, signed, and dated by QA. 

The FAT provides evidence that the hardware and software are fully integrated, that they operate as indicated in the computer system specification deliverable, and meet the expectations of the user as defined in the requirements specification deliverable. This final formal integration test should be completed in an environment very similar to the operational environment. The system can be subjected to a real-world environment by using emulators and/or simulators which mimic system interfaces. The user s representative should evaluate the supporting documents, the operation, system functionality, and system reliability. 

The difference between a DCS, where the HMI is usually an integral part of the system, and a PLC, which usually contains a controller and an HMI, is that separate software and hardware design specifications exist, and there will be separate build and Module Testing. Additionally, Integration Tests must take place to ensure that the individual systems communicate and interact in the correct manner. Any assessment of the potential hazards of such a system, such as a Computer HAZard and OPerabiUty (CHAZOP) smdy, should cover the total system. 

Since Module and Integration Testing is done in isolation from the process and equipment, confirmatory tests are required, and these form part of the OQ. Before this can be completed, proof is required that hardware and software are installed correctly. This is done at IQ, which ensures that all the PLC-based system components are present and installed correctly in accordance with design specifications. Some representative IQ tests are included in Table 24.2. 

Testing is condncted in several phases depending on the complexity of the software design. The snpplier shall be responsible for developing modnle, integration, factory, and site acceptance test specifications to demonstrate that the design has been fully and accurately implemented. 

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