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
Compliance + collaboration
We needed a solution that would augment our workflows to keep the drug development on track, regardless of the location of each team. I had come across Egnyte a couple of times and with a little more investigation saw greater potential than performance alone.”
A centralized repository with compliance baked in
Bio-Techne needed a single source of truth for all files, everywhere. Security was important, not only for IP, but for data regulation compliance, including 21 CFR Part 11. The solution needed to be compliant, secure, scalable, user-friendly and cost-effective.
No more data 'hide and seek'
"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. There is no more hide and seek with our data."
A platform that grows with your needs
At Decibel Therapeutics, we leverage Egnyte for our critical data management needs. It supports use cases like large scientific data sets, and provides much-needed governance and security to protect our IP. Egnyte's platform has allowed us to scale from our founding through to our subsequent phases of growth.
Trusted by Over 16,000 Businesses Worldwide
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.
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.
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
Best Practices for GxP Validation
Not sure where to start in modernizing your GxP practices? Start here.Read More
GxP Buyer’s Guide
Identify specific requirements for purchasing and implementing software to manage regulated...Download Now