SECURE ENCLAVE SOLUTION

GxP Compliance

Data integrity, quality and compliance with FDA 21 CFR Part 11

GxP Compliance for Emerging Biotechs

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 to Patient

Achieve rapid validation without slowing down the pace of innovation.

Unified Compliance

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

Optimized Workflows

Increase process efficiency through automated review and approval workflows.

GxP Compliance Made Easy

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 & 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 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

GxP Enterprise

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

Over 600 Life Sciences Customers Trust Egnyte

It's been exciting to see the Egnyte product offering evolve in a way that fits extremely well with the way that biotech companies start and grow. These GXP offerings are something that early biotech companies can lean into to accelerate their launch into clinical stage operations.

John Keilty

Venture Partner , Third Rock Ventures

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We are putting all documentation submitted to FDA and other regulatory agencies in Egnyte, so that now and in the future, people know where to find the actual documentation that was given to the agencies for review.

Heather Wolff

Vice President, Clinical Development Operations, Decibel Therapeutics

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As a small molecule R&D organization, we have work going on internally and externally. As that data comes back in from the CRO, information is automatically stored in a logical folder structure so it is organized and sent to our cloud computing platform for processing.