Egnyte GxP Compliance

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

gxp compliance portal with file reports option

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. From managing regulated documents to ensuring data integrity, Egnyte gives you visibility and control over your most valuable assets- your data, all while adding a layer of regulatory compliance that doesn’t distract from the way you work.

Over 600 Life Sciences Customers
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Trusted by Over 16,000 Businesses Worldwide

Bio Techne
Decibel Therapeutics
Fulcrum Therapeutics
Sygnature Discovery
Scientific Protein Laboratories

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.

file reports screenshot to analyze the detailed history of files and folders

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.

Ramp Up Your Quality Process

Egnyte for Life Sciences Quality is tailor-made for emerging life sciences companies. Our features enable an effective quality management process by facilitating collaboration, complying with regulatory requirements, and reducing the administrative burden of maintaining quality documents.

new workflow screenshot showing approval steps

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.

Our Users Have Spoken. Again.
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From a single platform, Egnyte for Life Sciences enables

Egnyte for Life Sciences enables Regulatory Compliance Solutions for GxP

Additional Resources


Best Practices for GxP Validation

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

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GxP Risk Assessment

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

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