Egnyte for Life Sciences

Egnyte for Life Sciences is a cloud-based content management platform designed for biotech, pharmaceutical, and medical device companies. It provides data governance, regulatory compliance support, and collaboration tools across the full R&D lifecycle, serving over 600 life sciences organizations worldwide.

The platform addresses four core functional areas — clinical operations, quality and regulatory compliance, research and development, and data governance — with capabilities tailored to the specific regulatory and operational requirements of life sciences teams, including support for FDA 21 CFR Part 11, Annex 11, GDPR, HIPAA, and GxP standards.

Clinical Operations

• Manages clinical trial data and supports inspection readiness
• Enables secure collaboration with clinical sites and contract research organizations (CROs)
• Provides real-time access to research data, protocols, and regulatory documents for distributed teams

Quality and Regulatory Compliance

• Maintains controlled documents with version control
• Automates compliance workflows and regulatory submission processes
• Supports 21 CFR Part 11-compliant electronic signatures
• Provides audit trail reports that are accessible and inspection-ready for GxP customers
• Keeps the platform in a continuously validated state with documentation available to all GxP customers

Research and Development

• Secures sensitive research data and intellectual property
• Manages statistical computing environments
• Supports scalable storage, advanced search, metadata tagging, and lifecycle management for unstructured data such as lab reports, images, and research documents

Data Governance

• Automatically monitors compliance across content
• Enforces granular, role-based access controls
• Establishes comprehensive audit trails for traceability across the data lifecycle
• Provides intelligent data governance for R&D, clinical, and regulatory teams

Document Portal

• Simplifies document collection using pre-configured templates, on-demand requests, and automated reminders
• Provides a custom-branded portal for external collaborators to handle secure uploads, reviews, and e-signatures
• Integrates validation workflows to accelerate document review and reduce redundancies
• Maintains compliance visibility through comprehensive audit logs and real-time reporting

AI-Powered Capabilities

• AI-powered document summary and Q&A
• AI-powered metadata tagging and document type classification
• AI Agents and AI Safeguards available as part of the broader Egnyte platform

Platform Plans

• Standard: Includes cloud, mobile, and desktop collaboration; Microsoft and Google co-editing; AI-powered document summary and Q&A; life sciences workflows; and probable ransomware detection. Priced at $22 per user per month, billed annually.
• Professional: Includes everything in Standard, plus watermarking, document type classification, content safeguards, privacy and compliance monitoring, and advanced snapshot and recovery. Custom pricing.
• GxP with Governance: Includes GxP validation, life sciences quality and quality training, life sciences workflows, secure collaboration, document type classification, and probable ransomware detection. Custom pricing.

Key Platform Features

• Centralized data access with role-based permissions
• Encryption, access control, and real-time monitoring to protect sensitive data
• Document version control and automated workflows
• Integrations with Microsoft 365, Google Workspace, Salesforce, and other applications
• Deployment options via Google Cloud, Microsoft Azure, and AWS
• PDF annotation and e-signature capabilities
• Project Hub for team coordination

Egnyte for Life Sciences is available to both emerging and established life sciences organizations. The platform is designed to support regulatory inspection readiness and integrates with a broad ecosystem of technology partners, cloud providers, and laboratory or clinical systems relevant to biotech, pharma, and medical device workflows.