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83 lines
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Plaintext
83 lines
4.0 KiB
Plaintext
<header id="pagmt">
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<h1>EU GMP Annex 11</h1>
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<p>Computerised Systems Compliance</p>
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</header>
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<section>
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<h3>Introduction</h3>
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<p>Annex 11 is part of the EU Guidelines for Good Manufacturing Practice (GMP) and sets out the requirements for
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computerised systems used in GMP-regulated activities. Published by the European Commission, it applies to all
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forms of computerised systems used as part of GMP-regulated activities, whether used for manufacturing, quality
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control, or quality assurance processes.
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<br /><br />
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<a href="https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en">Learn more about EU GMP guidelines.</a>
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</p>
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<h3>OneUptime's Annex 11 Compliance</h3>
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<p>OneUptime is certified compliant with EU GMP Annex 11 requirements. Our platform meets the European regulatory
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standards for computerised systems, enabling organisations operating under EU GMP regulations to use OneUptime
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as part of their validated environments.</p>
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<h3>Key Compliance Areas</h3>
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<h4>Risk Management</h4>
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<ul>
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<li>Risk assessments performed throughout the system lifecycle</li>
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<li>Documented risk management decisions proportionate to system criticality</li>
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<li>Regular risk reviews as part of periodic system evaluations</li>
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</ul>
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<h4>Personnel</h4>
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<ul>
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<li>Defined roles and responsibilities for system administration and use</li>
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<li>Training documentation for all personnel interacting with the system</li>
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<li>Separation of duties between development, testing, and production</li>
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</ul>
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<h4>Suppliers and Service Providers</h4>
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<ul>
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<li>Formal quality agreements available for regulated customers</li>
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<li>Supplier audit support and assessment documentation</li>
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<li>Documented competence and reliability of OneUptime as a service provider</li>
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</ul>
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<h4>Operational Phase</h4>
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<ul>
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<li><strong>Data Integrity:</strong> Controls ensuring data is accurate, complete, and maintained throughout
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its lifecycle</li>
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<li><strong>Accuracy Checks:</strong> Built-in validation of data at input and processing stages</li>
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<li><strong>Data Storage:</strong> Secure, redundant storage with protection against damage and loss</li>
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<li><strong>Printouts:</strong> Ability to obtain clear, legible copies of electronically stored data</li>
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<li><strong>Audit Trail:</strong> Comprehensive, tamper-evident audit trails recording all GMP-relevant changes</li>
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<li><strong>Change and Configuration Management:</strong> Controlled change processes with impact assessment
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and approval workflows</li>
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<li><strong>Security:</strong> Physical and logical security controls including access management and
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authentication</li>
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<li><strong>Incident Management:</strong> Documented procedures for reporting and managing system incidents</li>
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<li><strong>Electronic Signatures:</strong> Legally binding electronic signatures equivalent to handwritten
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signatures</li>
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<li><strong>Batch Release:</strong> Support for electronic batch record review and release processes</li>
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<li><strong>Business Continuity:</strong> Disaster recovery and business continuity provisions to ensure
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data availability</li>
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</ul>
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<h3>Relationship with 21 CFR Part 11</h3>
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<p>Annex 11 and <a href="/legal/21-cfr-part-11">21 CFR Part 11</a> share many common requirements. OneUptime's
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compliance with both frameworks ensures that organisations operating across US and EU regulatory environments
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can rely on a single platform that meets both sets of requirements.</p>
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<h3>Request Compliance Documentation</h3>
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<p>For detailed Annex 11 compliance documentation or to discuss how OneUptime meets your EU GMP requirements,
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please contact us at
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<a href="mailto:compliance@oneuptime.com">compliance@oneuptime.com</a>.</p>
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</section>
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