GxP Compliance

Data integrity, quality and compliance with FDA 21 CFR Part 11.
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GxP Compliance for Emerging Biotech

From managing regulated documents to ensuring data integrity, Egnyte is the easiest way for emerging biotechs to get over the compliance hurdle. Effective and efficient clinical data management gets you to trial completion faster.

Speed and Complaince

Speed to Patient

Achieve rapid validation without slowing down the pace of innovation.

Unified Compliance

Unified Compliance

Facilitate management of regulatory and unregulated content with a single, centralized data repository.

Optimized Workflows

Optimized Workflows

Increase process efficiency through automated review and approval workflows.

GxP Compliance Made Easy

Compliant

21 CFR Part 11 Compliant

Comply with regulatory requirements when creating, storing and managing GxP-regulated documents. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance.

Easy to Implement

Easy to Implement & Manage

Establish a regulated environment accessible only to credentialed employees and external partners, whether your compliance envelope covers all your documents or just a single type. Use the compliance portal, as a central hub to facilitate auditing, validation, and reporting.

Ramp Up Your Quality Process

Ramp Up Your Controlled Documentation Process

Enable an effective document management process by facilitating collaboration, complying with regulatory requirements, and reducing the administrative burden of maintaining controlled documents.

The Power of Many Solutions In One Turnkey Platform

Egnyte’s modular offerings grow with your company through all development and approval phases - from startup to scale up.

GxP Enterprise Lite

  • GxP Compliance Portal
  • Audit Trails
  • Multi-Step Workflows
  • Data Lifecycle Management

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GxP Enterprise

  • GxP Compliance Portal
  • Audit Trails
  • Rapid Validation
  • Content Safeguards
  • Ransomware Detection & Recovery

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Over 600 Life Sciences Customers Trust Egnyte

See Egnyte GxP in Action

Life Sciences

Egnyte for Life Sciences Streamlines GxP Compliance

  • Validate systems with Part 11-compliant documents
  • Automate regulated document management with multi-step review and approval
  • Maintain audit-readiness with file versioning and audit trail reporting 

Speak with an Egnyte Life Sciences Specialist Today