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Part of Our Complete
Life Sciences Suite
Egnyte helps clinical, quality, and regulatory teams collaborate securely and manage critical data while meeting industry requirements like GxP, ICH E6(R3), and 21 CFR Part 11.
Why Life Sciences Teams
Choose Egnyte
Egnyte gives life sciences teams a secure platform to manage regulated
content, support GxP workflows, and maintain inspection-readiness—all
in one place.
Built for SOPs and Document Control
Control regulated content lifecycle with versioning, eSignatures, and review workflows.
Capabilities:
- Version control with approvals
- Automated e-signature routing
- Change tracking and document logs
Engineered for QMS and CAPA Workflows
Centralize corrective actions, deviations, and controlled documents in one system.
Capabilities:
- Link CAPAs to SOPs and WIs
- Route for approval and review
- Store evidence for audits
Optimized for Training and Readiness
Support employee readiness with audit-ready access to the latest documents.
Capabilities:
- Manage user training records
- Link to controlled documents
- Report on completions and gaps
How Life Sciences
Teams Work With Egnyte
Streamline quality operations with audit-ready collaboration
Document Control
Manage versioning, approvals, and e-signatures for SOPs, WIs, and policies in a secure, compliant repository.
Audit Readiness
Maintain real-time audit trails, metadata, and activity logs to support inspections and internal
reviews.
reviews.
Training Management
Track training assignments, completions, and related documents for seamless readiness across regulated teams.
Regulatory Submissions
Collaborate across stakeholders with validated file exchange and centralized content to support timely submissions.
BridgeBio Builds a Centralized Hub for Smarter Collaboration and Governance
“We chose Egnyte for its compliance capabilities and expertise in understanding the rigors of a validated, compliant data management platform.”
Revolution Machines Provides External Collaborators With Fast, Easy Access to Data
“We have over 200 controlled folders in Egnyte permissioned specifically for externalcollaborators and can govern access rights with the click of a button.”
MOMA Therapeutics Simplified Lab-to-Cloud Data Flows and Streamlined CRO Collaboration
“We can see exactly who has access to what, who is downloading and deleting content, and whether they’re doing so appropriately.”
Built for Life Sciences Compliance
and Security Requirements
GxP Content Controls
-
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
-
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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Elevate Compliance Readiness and Optimize Quality Management
Secure, compliant, and collaborative— Egnyte is built for regulated teams.