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    <h1>21 CFR Part 11</h1>

    <p>Electronic Records and Electronic Signatures Compliance</p>

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    <h3>Introduction</h3>

    <p>Title 21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes
        criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and
        equivalent to paper records and handwritten signatures. It applies to all FDA-regulated industries, including
        pharmaceuticals, biotechnology, medical devices, and food manufacturing.
        <br /><br />
        <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11">You can read the full regulation here.</a>
    </p>

    <h3>OneUptime's 21 CFR Part 11 Compliance</h3>

    <p>OneUptime is certified compliant with 21 CFR Part 11 requirements. Our platform provides the controls and
        capabilities necessary for organizations operating in FDA-regulated environments to use OneUptime as part of
        their validated systems.</p>

    <h3>Key Compliance Controls</h3>

    <p>OneUptime implements the following controls in alignment with 21 CFR Part 11:</p>

    <ul>
        <li><strong>Audit Trails:</strong> Comprehensive, immutable audit trails that capture all record creation,
            modification, and deletion events, including timestamps, user identification, and the nature of each action.</li>
        <li><strong>Access Controls:</strong> Role-based access controls (RBAC) ensuring that only authorized individuals
            can access, create, modify, or delete electronic records.</li>
        <li><strong>Electronic Signatures:</strong> Unique user authentication with individual account credentials,
            ensuring electronic signatures are attributable to a specific individual.</li>
        <li><strong>Data Integrity:</strong> Controls to ensure that electronic records are accurate, complete, and
            protected from unauthorized alteration throughout their retention period.</li>
        <li><strong>System Validation:</strong> Documentation and qualification support (IQ/OQ/PQ) to assist customers
            with their system validation requirements.</li>
        <li><strong>Authority Checks:</strong> Verification that only authorized individuals can use the system, sign
            records, or alter electronic signatures.</li>
        <li><strong>Record Retention:</strong> Configurable data retention policies that ensure records are preserved for
            their required retention periods and can be retrieved in a readable format.</li>
    </ul>

    <h3>Subpart B — Electronic Records</h3>

    <p>OneUptime addresses the requirements of Subpart B, including:</p>

    <ul>
        <li>Controls for closed systems with appropriate access management</li>
        <li>Tamper-evident audit trails with computer-generated timestamps</li>
        <li>Operational system checks to enforce permitted sequencing of events</li>
        <li>Device checks to ensure data validity at points of input and output</li>
        <li>Encryption to protect records transmitted over open networks</li>
    </ul>

    <h3>Subpart C — Electronic Signatures</h3>

    <p>OneUptime supports Subpart C requirements, including:</p>

    <ul>
        <li>Electronic signatures that are unique to one individual and not reused or reassigned</li>
        <li>Identity verification before establishing or assigning electronic signatures</li>
        <li>Signatures that include the printed name, date, time, and meaning of the signing</li>
        <li>Controls to ensure signatures are linked to their respective electronic records</li>
    </ul>

    <h3>Request Compliance Documentation</h3>

    <p>For detailed compliance documentation, validation support materials, or to discuss how OneUptime meets your
        organization's 21 CFR Part 11 requirements, please contact us at
        <a href="mailto:compliance@oneuptime.com">compliance@oneuptime.com</a>.</p>

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