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    <h1>GAMP 5</h1>

    <p>Good Automated Manufacturing Practice Compliance</p>

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    <h3>Introduction</h3>

    <p>GAMP 5 (Good Automated Manufacturing Practice) is a set of guidelines published by the International Society for
        Pharmaceutical Engineering (ISPE) for the validation of computerized systems in the pharmaceutical and life
        sciences industries. It provides a risk-based approach to compliant GxP computerized systems, ensuring that
        automated systems used in regulated environments are fit for their intended purpose.
        <br /><br />
        <a href="https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition">Learn more about GAMP 5 from ISPE.</a>
    </p>

    <h3>OneUptime's GAMP 5 Compliance</h3>

    <p>OneUptime is validated in accordance with GAMP 5 guidelines. As a configurable software product, OneUptime is
        classified as a GAMP 5 Category 4 system. We provide comprehensive validation documentation and support to help
        our customers meet their regulatory obligations.</p>

    <h3>Software Category Classification</h3>

    <p>Under GAMP 5, OneUptime is classified as:</p>

    <ul>
        <li><strong>Category 4 — Configured Product:</strong> OneUptime is a commercially available software product that
            is configured to meet specific business and regulatory requirements. Configuration is managed through
            well-defined settings and does not require custom code modifications.</li>
    </ul>

    <h3>Validation Approach</h3>

    <p>OneUptime follows the GAMP 5 V-Model lifecycle approach:</p>

    <ul>
        <li><strong>User Requirements Specification (URS):</strong> Clear documentation of intended use and regulatory
            requirements that OneUptime fulfills.</li>
        <li><strong>Functional Specification (FS):</strong> Detailed description of system functionality and configuration
            options available to regulated users.</li>
        <li><strong>Installation Qualification (IQ):</strong> Verification that OneUptime is correctly installed and
            configured according to specifications.</li>
        <li><strong>Operational Qualification (OQ):</strong> Testing to confirm that OneUptime operates as intended across
            all specified operating ranges and conditions.</li>
        <li><strong>Performance Qualification (PQ):</strong> Verification that OneUptime consistently performs as expected
            under real-world operating conditions.</li>
    </ul>

    <h3>Risk-Based Approach</h3>

    <p>In alignment with GAMP 5 principles, OneUptime employs a risk-based approach to validation that includes:</p>

    <ul>
        <li>Risk assessments to identify and mitigate potential impacts on data integrity and patient safety</li>
        <li>Proportionate testing efforts based on system complexity and risk level</li>
        <li>Documented change control procedures for system updates and configuration changes</li>
        <li>Periodic review processes to ensure continued validated state</li>
    </ul>

    <h3>Validation Documentation Package</h3>

    <p>OneUptime provides a comprehensive validation package to support customer qualification activities, including:</p>

    <ul>
        <li>System description and architecture documentation</li>
        <li>IQ/OQ/PQ protocol templates</li>
        <li>Traceability matrices</li>
        <li>Release notes and change history</li>
        <li>Supplier audit support documentation</li>
    </ul>

    <h3>Request Validation Documentation</h3>

    <p>For GAMP 5 validation documentation or to discuss how OneUptime supports your computerized system validation
        requirements, please contact us at
        <a href="mailto:compliance@oneuptime.com">compliance@oneuptime.com</a>.</p>

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