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.

Granular Access and
Sharing Controls

Egnyte empowers life-sciences teams with role-based permissions, secure enclaves, and compliant data sharing for CROs and partners.


Capabilities:
  • Enable role-based permissions across internal and external users
  • Offer secure, compliant collaboration with CROs, sites, and partners
  • Use secure enclaves for statistical and regulated data

Unified Audit Trails and
Compliance Monitoring

Egnyte enables centralized audit logs, regulatory compliance control (FDA/EMA/ICH), and custom file-status categories for robust lifecycle tracking.


Capabilities:
  • Centralize audit logs and track activity for regulated files
  • Implement built-in controls for FDA, EMA, ALCOA+, and ICH E6 (R3) compliance
  • Create up to 50 custom categories with up to 10 configurable document statuses to better manage events, including CAPAs and deviations

Controlled Quality Events

Standardize how teams manage CAPAs, deviations, and quality events while maintaining traceability and regulatory alignment across studies.


Capabilities:
  • Manage CAPAs and deviations centrally
  • Deploy traceable quality event workflows
  • Link related documents to quality events

How Life Sciences
Teams Work With Egnyte

Strengthen governance and mitigate risk across the data lifecycle.

UnifiedVisibility

Unified Visibility

Gain full control over unstructured content with AI-powered classification, tagging, and lineage tracing across your GxP, clinical, and non-clinical content.
RiskReduction

Risk Reduction

Identify sensitive, outdated, or orphaned files before they become a problem—reducing compliance risks and streamlining data retention policies.
Egnyte Document Control Feature

Access Control

Apply fine-grained, role-based permissions to restrict access to regulated content and enforce policies across internal teams, CROs, and vendors.
Egnyte Audit Readiness Feature

Audit Readiness

Ensure inspection readiness with automated audit trails, version history, and activity logging aligned with 21 CFR Part 11 and ALCOA+ principles.

Built for Life Sciences Compliance
and Security Requirements

GxP Content Controls

  • Audit-Ready Trials

    Audit-Ready Trials

    Track every action for inspection readiness and regulatory compliance.
  • Granular Permissions

    Granular Permissions

    Limit folder and document access by role, site, or study milestone.
  • Automated Workflows

    Automated Workflows

    Enforce review, approval, and release for controlled documents.

21 CFR Part 11 Compliance

  • E-Signature Support

    E-Signature Support

    Capture and manage electronic signatures per FDA guidelines.
  • Version Control

    Version Control

    Maintain strict control over revisions of regulated documents.
  • Controlled Record Retention

    Controlled Record Retention

    Maintain required document histories with validated storage policies.

Explore More Resources

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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.