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Application Software |
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Our years of expertise in software development applications enable us to provide the most user-friendly solutions for operating medical devices, running processes in the pharmaceutical industry, and running experiments in biomedical labs. Our commitment is to not only complete FDA regulations in software development, but also to consider interoperability of the software with different platforms. Our stringent validation and testing requirements ensure our clients top-notch quality software applications. |
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Software Validation |
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Requirements and Specifications |
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Verification and Validation - Our software verification and validation includes confirmation by examination and providing objective evidence that software specifications conform to user needs and intended uses. Particular requirements implemented through software can be consistently fulfilled |
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For user site software validation we organize our validation task in terms of IQ/OQ/PQ: |
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Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) |
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We follow software development under a highly-controlled environment; we understand the complexity and importance of software development. We consider software development to be the key to the success of any medical device or process used by biomedical labs and the pharmaceutical industry.
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Software Testing |
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We follow strict principles to foster effective examination of a software product.
Our software testing is performed not only by Software Developers (White box testing), but also by a Quality Engineer (Black box testing) who confirms the quality and user friendliness of the software. Our commitment to provide quality software not only ensures coding accuracy and detailed design specifications, but also includes monitoring of end-user experience with the software |
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For process testing , User site testing includes completion of the following tasks |
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Acceptance Test Execution |
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Test Results Evaluation |
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Error Evaluation/Resolution |
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Final Test Report |
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Design Review |
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Our software design review is very strict and allows us to meet all goals and requirements defined in the software validation plan.
Have the appropriate tasks, expected results, outputs, or products been established for each software life cycle activity? |
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Do they comply with the requirements of other software life cycle activities in terms of correctness, completeness, consistency, and accuracy? |
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Do they satisfy the standards, practices, and conventions of that activity? |
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Do they establish a proper basis for initiating tasks for the next software life cycle activity? |
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Our understanding of the benefits of software validation will help our client be more successful in the industry and will help us reduce your costs, making it easier and more economical to change software reliably and revalidate any changes. |
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