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    Overview

    Guarantee the use of electronic technology instead of high cost, time consuming paper systems. This is the objective of the validation services offered by SoftExpert.

    As part of our methodology, we provide confirmation by examination and provision of objective evidence that your computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled in a regulatory compliant manner.

    The Validation Services are evidence of SoftExpert solution conformity with the FDA 21 CFR part 11 regulations. This ensures that electronic records and signatures are considered as trustworthy, reliable and legally valid as paper records.

    System Acceptance Test
    SoftExpert Validation Toolkit
    System Acceptance Test

    System Acceptance Test

    The System Acceptance Test service provides application acceptance to ensure conformity with the specified technical and functional requirements.

    The application acceptance process is based on a functional test plan, prepared in advance, which gives the customer a better understanding of the contents, structure and mechanism of the test. It also contains the necessary details to guarantee the test can ensure the application meets the requirements, if it is stable and whether or not the new functions or modifications affect the existing functions.

    The test plan contains standard system function/resource scenarios. The drawing up of specific customer scenarios and test execution mentoring with users performed by a SoftExpert professional can be acquired separately with consulting services.

    Customer Benefits

    • Prior identification of how to deal with the requirements.
    • Clear identification of acceptance criteria.
    • History of test execution results.
    • Assurance that application adheres to the functional requirements and to the company’s business.

    Main Activities

    • Provide standard functional test plan per application.
    • Draw up specific functional test plan, according to customer needs and requirements. (*)
    • Follow test plan execution with the customer’s system users, as well as draw up and provide a report showing results of the tests performed. (*)

    Main Deliverables

    • Standard functional test plan per application.
    • Specific functional test plan. (*)
    • Test plan execution record with report of obtained results. (*)
    SoftExpert Validation Toolkit

    SoftExpert Validation Toolkit

    It takes some pretty expensive knowledge and specialized skills to create compliant validation documentation. We help you do it comprehensively and cost effectively.

    SoftExpert Validation Toolkit is a detailed collection of templates, forms and scripts designed to help your validation project team members complete the requirements for validation projects. The toolkit consists of project-level templates of validation documentation items such as User Requirements Specification (URS), Functional Specifications (FS), System Acceptance Test Plan and other valuable documents to system validation.

    About User Requirement Specification

    Although each organization will likely have a unique User Requirements Specification (URS) based on its own operating policy, quality directives, validation needs and regulatory requirements, a generalized URS structure is self-contained in the toolkit. This structure can assist in development of a custom URS or can be adopted where special and/or additional requirements are unnecessary.

    Should your organization decide to perform the SoftExpert applications validation itself, SoftExpert Validation Toolkit will enhance your process productivity.

    Customer Benefits

    • Standard documentation in full adherence with SoftExpert applications.
    • Firm understanding of solution requirements and market standards.
    • Adherence to GAMP (Good Automated Manufacturing Practice).
    • Makes the SoftExpert application validation process quick and easy.
    • Guarantees data legitimacy and conformity.
    • Enables efforts to be concentrated on high value added activities.

    Main Activities

    • Provide project-level documentation with SoftExpert application standard scenarios.

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