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    <h1>EU GMP Annex 11</h1>

    <p>Computerised Systems Compliance</p>

</header>

<section>

    <h3>Introduction</h3>

    <p>Annex 11 is part of the EU Guidelines for Good Manufacturing Practice (GMP) and sets out the requirements for
        computerised systems used in GMP-regulated activities. Published by the European Commission, it applies to all
        forms of computerised systems used as part of GMP-regulated activities, whether used for manufacturing, quality
        control, or quality assurance processes.
        <br /><br />
        <a href="https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en">Learn more about EU GMP guidelines.</a>
    </p>

    <h3>OneUptime's Annex 11 Compliance</h3>

    <p>OneUptime is certified compliant with EU GMP Annex 11 requirements. Our platform meets the European regulatory
        standards for computerised systems, enabling organisations operating under EU GMP regulations to use OneUptime
        as part of their validated environments.</p>

    <h3>Key Compliance Areas</h3>

    <h4>Risk Management</h4>
    <ul>
        <li>Risk assessments performed throughout the system lifecycle</li>
        <li>Documented risk management decisions proportionate to system criticality</li>
        <li>Regular risk reviews as part of periodic system evaluations</li>
    </ul>

    <h4>Personnel</h4>
    <ul>
        <li>Defined roles and responsibilities for system administration and use</li>
        <li>Training documentation for all personnel interacting with the system</li>
        <li>Separation of duties between development, testing, and production</li>
    </ul>

    <h4>Suppliers and Service Providers</h4>
    <ul>
        <li>Formal quality agreements available for regulated customers</li>
        <li>Supplier audit support and assessment documentation</li>
        <li>Documented competence and reliability of OneUptime as a service provider</li>
    </ul>

    <h4>Operational Phase</h4>
    <ul>
        <li><strong>Data Integrity:</strong> Controls ensuring data is accurate, complete, and maintained throughout
            its lifecycle</li>
        <li><strong>Accuracy Checks:</strong> Built-in validation of data at input and processing stages</li>
        <li><strong>Data Storage:</strong> Secure, redundant storage with protection against damage and loss</li>
        <li><strong>Printouts:</strong> Ability to obtain clear, legible copies of electronically stored data</li>
        <li><strong>Audit Trail:</strong> Comprehensive, tamper-evident audit trails recording all GMP-relevant changes</li>
        <li><strong>Change and Configuration Management:</strong> Controlled change processes with impact assessment
            and approval workflows</li>
        <li><strong>Security:</strong> Physical and logical security controls including access management and
            authentication</li>
        <li><strong>Incident Management:</strong> Documented procedures for reporting and managing system incidents</li>
        <li><strong>Electronic Signatures:</strong> Legally binding electronic signatures equivalent to handwritten
            signatures</li>
        <li><strong>Batch Release:</strong> Support for electronic batch record review and release processes</li>
        <li><strong>Business Continuity:</strong> Disaster recovery and business continuity provisions to ensure
            data availability</li>
    </ul>

    <h3>Relationship with 21 CFR Part 11</h3>

    <p>Annex 11 and <a href="/legal/21-cfr-part-11">21 CFR Part 11</a> share many common requirements. OneUptime's
        compliance with both frameworks ensures that organisations operating across US and EU regulatory environments
        can rely on a single platform that meets both sets of requirements.</p>

    <h3>Request Compliance Documentation</h3>

    <p>For detailed Annex 11 compliance documentation or to discuss how OneUptime meets your EU GMP requirements,
        please contact us at
        <a href="mailto:compliance@oneuptime.com">compliance@oneuptime.com</a>.</p>

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