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85 lines
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85 lines
4.0 KiB
Plaintext
<header id="pagmt">
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<h1>GxP Cloud Compliance</h1>
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<p>Cloud Infrastructure Qualification for Regulated Environments</p>
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</header>
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<section>
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<h3>Introduction</h3>
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<p>GxP Cloud Compliance addresses the regulatory requirements for using cloud-based services in GxP-regulated
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environments. As regulatory agencies including the FDA, EMA, and MHRA have issued guidance on the use of cloud
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computing in regulated industries, organisations must ensure that their cloud service providers maintain
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appropriate controls to support GxP compliance.
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</p>
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<h3>OneUptime's GxP Cloud Qualification</h3>
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<p>OneUptime provides a comprehensive GxP Cloud Qualification Package that enables regulated customers to qualify
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our cloud-hosted platform for use in GxP environments. Our cloud infrastructure and operational practices are
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designed to meet the expectations of global regulatory agencies for cloud-based GxP systems.</p>
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<h3>Infrastructure Qualification</h3>
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<p>OneUptime's cloud infrastructure qualification covers:</p>
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<ul>
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<li><strong>Infrastructure Qualification (IQ):</strong> Documentation verifying that our cloud infrastructure
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is correctly provisioned, configured, and meets defined specifications.</li>
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<li><strong>Operational Qualification (OQ):</strong> Evidence that our cloud environment operates correctly
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under normal and stress conditions.</li>
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<li><strong>Performance Qualification (PQ):</strong> Demonstrated consistent performance of the cloud platform
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under production workloads.</li>
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</ul>
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<h3>Key Compliance Controls</h3>
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<ul>
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<li><strong>Data Sovereignty:</strong> Clear documentation of data storage locations with options for regional
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data residency to meet local regulatory requirements.</li>
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<li><strong>Data Segregation:</strong> Logical separation of customer data ensuring no cross-contamination
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between tenants.</li>
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<li><strong>Encryption:</strong> Data encrypted at rest (AES-256) and in transit (TLS 1.2+) across all
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cloud services.</li>
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<li><strong>Backup and Recovery:</strong> Automated backup procedures with documented recovery time objectives
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(RTO) and recovery point objectives (RPO).</li>
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<li><strong>Change Management:</strong> Controlled deployment processes with documented change records,
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impact assessments, and rollback capabilities.</li>
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<li><strong>Monitoring and Alerting:</strong> Continuous infrastructure monitoring with automated alerting
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for security events and performance anomalies.</li>
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<li><strong>Access Controls:</strong> Strict access management for cloud infrastructure with multi-factor
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authentication and privileged access management.</li>
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</ul>
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<h3>Shared Responsibility Model</h3>
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<p>OneUptime provides clear documentation of the shared responsibility model, defining:</p>
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<ul>
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<li>Responsibilities managed by OneUptime (platform security, infrastructure, patching, backups)</li>
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<li>Responsibilities managed by the customer (user access, configuration, data classification)</li>
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<li>Shared responsibilities (incident response, compliance monitoring)</li>
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</ul>
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<h3>Regulatory Alignment</h3>
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<p>OneUptime's GxP Cloud Compliance aligns with guidance from:</p>
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<ul>
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<li>FDA — Use of cloud computing in GxP-regulated environments</li>
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<li>EMA — Cloud computing guidance for regulated entities</li>
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<li>MHRA — Data integrity and cloud computing expectations</li>
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<li>PIC/S — Good practices for computerised systems in regulated environments</li>
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</ul>
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<h3>Request Qualification Package</h3>
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<p>For the GxP Cloud Qualification Package or to discuss how OneUptime's cloud infrastructure meets your regulated
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environment requirements, 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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