GxP Compliance

Egnyte GxP Compliance is a regulated content management platform designed for life sciences organizations, with a particular focus on emerging biotechs navigating FDA 21 CFR Part 11 requirements. The platform provides a centralized, validated environment for managing GxP-regulated documents, supporting data integrity, audit readiness, and controlled documentation processes from early-stage R&D through clinical development and regulatory submission.

The platform is positioned as a turnkey solution that consolidates regulated and unregulated content management into a single repository, reducing the administrative overhead typically associated with maintaining compliance in a clinical or research setting. Over 600 life sciences customers use Egnyte, including organizations managing CRO data intake, regulatory agency submissions, and clinical stage operations.

Core Compliance Capabilities

• Native support for FDA 21 CFR Part 11 compliance, covering the creation, storage, and management of GxP-regulated documents
• Audit trails to track document activity and support regulatory inspections
• Checksums for data integrity verification
• Robust access control to restrict the regulated environment to credentialed employees and external partners
• File versioning to maintain a complete document history
• Audit trail reporting to support ongoing audit readiness

Document and Workflow Management

• Multi-step review and approval workflows to automate regulated document management
• Automated folder structures for organizing incoming data, including data returned from CROs
• A compliance portal that serves as a central hub for auditing, validation, and reporting
• Support for both fully regulated environments and configurations covering only specific document types
• Data lifecycle management to govern content from creation through retention or disposal

Platform Tiers

• GxP Enterprise Lite includes the GxP Compliance Portal, audit trails, multi-step workflows, and data lifecycle management
• GxP Enterprise includes all Enterprise Lite features plus rapid validation, content safeguards, and ransomware detection and recovery

Key Use Cases

• Validating systems using Part 11-compliant documentation
• Managing regulatory submissions to the FDA and other agencies in a single, findable location
• Integrating with cloud computing platforms for downstream data processing
• Supporting clinical data management to accelerate trial completion
• Enabling collaboration with external partners such as CROs within a controlled, compliant environment

Egnyte GxP Compliance is offered as a modular platform designed to scale with an organization through all development and approval phases. It integrates with technology partners including Google Workspace, Microsoft 365, and Salesforce, and supports deployment on Google Cloud, Microsoft Azure, and AWS.