Egnyte GxP Compliance

Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.

Regulatory Compliance Solutions for GxP
and FDA 21 CFR Part 11

Developing a quality and compliance posture that meets the competing needs of business
and auditors is a tall order. Egnyte gives you visibility and control over your most valuable
asset—your data, all while adding a layer of regulatory compliance that doesn’t distract
from the way you work.

Over 400 Life Sciences Customers
Trust Egnyte with their Data

Trusted by Over 16,000 Businesses Worldwide

Bio Techne
Veeva
Decibel Therapeutics
Fulcrum Therapeutics
Sygnature Discovery
travere
TauRx
Scientific Protein Laboratories
S&ME
Joeris

GxP Compliance Made Easy

21 CFR Part 11 compliant

When creating, storing, and managing GxP-regulated documents, Egnyte for Life Sciences complies with regulatory requirements, like Part 11/Annex 11. The platform supports audit trails, checksums for data integrity, and robust access control for a simple yet effective path to GxP and 21 CFR Part 11 compliance.

solution-remote

Easy to implement & manage

Whether your compliance envelope covers all your documents or just a single type, we make it easy to set up a regulated environment accessible only to credentialed employees and external partners. Egnyte’s GxP compliance portal is a central hub to facilitate auditing, validation, and reporting.

Review & approval workflows

We have streamlined the process for anyone in your organization to initiate, review, and approve controlled documents with Part 11 compliant e-signatures. Flexible enough to handle single- and multi-step workflows, designated stakeholders can collaborate on and approve regulated documents.

Workflows

See Egnyte GxP in Action

Egnyte’s GxP features allow you to maintain compliance without modifying your existing workflows. No new training, no new steps, and we make administration a breeze. This democast showcases how life science companies can maintain GxP compliance using Egnyte for Life Sciences' audit trail capabilities.

Egnyte Ranked #1 for
Data-Centric Security by G2

From a single platform, Egnyte for Life Sciences enables

Egnyte for Life Sciences enables Regulatory Compliance Solutions for GxP

Additional Resources

eBook

Best Practices for GxP Validation

Not sure where to start in modernizing your GxP practices? Start here.

Read More
Solutions Brief

GxP Buyer’s Guide

Identify specific requirements for purchasing and implementing software to manage regulated...

Download Now
Solutions Brief

GxP Risk Assessment

Get our template for assessing and quantifying risk of your computer systems and if a system...

Learn More

Get Started with Egnyte Today