Featured eBook
Part of Our Complete Life
Sciences Suite
From lab to submission, Egnyte provides a cohesive platform for managing data, documents, and collaboration across research, clinical, and regulatory workflows.
Why Life Sciences Teams
Choose Egnyte
Egnyte provides life sciences teams with secure, role-based collaboration, centralized audit logs for compliance, and traceable workflows to seamlessly manage controlled quality events.
How Life Sciences
Teams Work With Egnyte
Strengthen governance and mitigate risk across the data lifecycle.
Unified Visibility
Gain full control over unstructured content with AI-powered classification, tagging, and lineage tracing across your GxP, clinical, and non-clinical content.
Risk Reduction
Identify sensitive, outdated, or orphaned files before they become a problem—reducing compliance risks and streamlining data retention policies.
Access Control
Apply fine-grained, role-based permissions to restrict access to regulated content and enforce policies across internal teams, CROs, and vendors.
Audit Readiness
Ensure inspection readiness with automated audit trails, version history, and activity logging aligned with 21 CFR Part 11 and ALCOA+ principles.
Forghorn Drove Critical Decision-Making With Full Visibility Into Sensitive Content Access
“The Egnyte team spent significant time to understand our data flow processes and assist us in developing the appropriate policies. We scheduled dedicated sessions to understand the data, create the policies, and fine-tune as needed.”
Nimbus Therapeutics Accelerated Deployment by Automating CRO Data
“We use Egnyte for data sharing across multiple external partners, taking advantage of their API, version control, secure links, content ownership, and metadata capture functionality.”
BridgeBio Builds a Centralized Hub for Smarter Collaboration and Governance
“Unlike other platforms where you have to work with third parties to build a compliance package, Egnyte’s end-to-end audit capabilities, security features, and ease of operation are already built-in.”
Built for Life Sciences Compliance
and Security Requirements
GxP Content Controls
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Audit-Ready Trials
Track every action for inspection readiness and regulatory compliance. -
Granular Permissions
Limit folder and document access by role, site, or study milestone. -
Automated Workflows
Enforce review, approval, and release for controlled documents.
21 CFR Part 11 Compliance
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E-Signature Support
Capture and manage electronic signatures per FDA guidelines. -
Version Control
Maintain strict control over revisions of regulated documents. -
Controlled Record Retention
Maintain required document histories with validated storage policies.
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Support for Data Governance Teams
Get expert guidance, proven best practices, and tailored onboarding to help deploy Egnyte quickly, drive adoption, and stay compliant as requirements evolve.
Frequently Asked Questions
Have more questions? Contact Sales to get the answer you’re looking for.
What does data governance mean for life sciences companies specifically?
Data governance in life sciences means controlling the complete lifecycle of clinical, regulatory, and quality data — from classification and access to retention and audit readiness. With regulations like GxP, ALCOA+, and 21 CFR Part 11 governing how data must be created, stored, and traced, life sciences teams need a purpose-built governance layer that treats content as a strategic, auditable asset.
How does Egnyte give life sciences teams visibility into their unstructured content?
Egnyte uses AI-powered classification and tagging to map where sensitive, clinical, and regulated content lives across your repositories — GxP and non-clinical alike — and traces data lineage across the content lifecycle. This gives governance and compliance teams a unified view of their data landscape without manually auditing individual files, and surfaces sensitive or orphaned content before it becomes a compliance risk.
How does Egnyte help life sciences organizations stay audit and inspection-ready?
Egnyte maintains automated audit trails, version history, and activity logs aligned with 21 CFR Part 11 and ALCOA+ principles — so inspection preparation is continuous, not a pre-audit scramble. Every action on regulated content is tracked and traceable, letting teams produce complete evidence packages for FDA, EMA, and ICH E6(R3) reviews without manual reconstruction across scattered systems.
How does Egnyte control data access for CROs, sites, and external partners?
Egnyte applies fine-grained, role-based permissions that restrict access to regulated content by role, site, or study milestone — enforced consistently across internal teams, CROs, and vendors. Secure enclaves protect statistical and regulated data, so life sciences organizations can share content with external partners at scale without exposing intellectual property or violating data governance policies.
How does Egnyte reduce compliance risk from sensitive, outdated, or orphaned files?
Egnyte identifies sensitive, outdated, and orphaned files before they create compliance exposure — streamlining retention policy enforcement and reducing the surface area for audit findings. Custom policies can detect specific content types, including scientific data, financial files, and PHI, and automatically apply classification, trigger review workflows, or surface findings through real-time governance dashboards.
How can Egnyte support AI adoption in a regulated life sciences environment?
Egnyte provides the governed content foundation that makes AI adoption safe in life sciences — ensuring AI tools only access properly classified, permissioned content. AI-powered classification automates metadata tagging and data routing, while AI Safeguards prevent sensitive regulated content from surfacing in AI responses for unauthorized users — keeping AI adoption aligned with GxP controls and compliance requirements.
What compliance frameworks does Egnyte support for life sciences data governance?
Egnyte supports the core frameworks governing life sciences data: GxP content controls, 21 CFR Part 11 for electronic records and signatures, ALCOA+ principles for data integrity, and ICH E6(R3) for clinical trial standards. Controls for FDA, EMA, and regulatory submissions are built into the platform — not assembled through third-party compliance packages — allowing organizations to implement and validate quickly.