Egnyte for Life Sciences

Unify your regulated data to reduce complexity and risk

Innovative life science companies rely on Egnyte to help them with compliance, collaboration & control of their data.

A Unified Platform for Life Sciences Data and Documents

Egnyte for Life Sciences provides a compliant, unified data management platform that enables visibility and control into your most valuable asset—your data. Our software provides a single environment for your R&D, business, quality documentation and regulated data. Further, our GxP-compliant environment means you can conform to regulatory requirements, like FDA 21 CFR Part 11, without distracting from your current workflows.

Unified Platform for Life Sciences Data and Documents Management

The Most Innovative Companies Use Egnyte

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.

Robert Kuhn

Director, IT Infrastructure & Security, Travere Therapeutics

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.

Chris Moxham Ph.D.

Senior Vice President Discovery Research, Fulcrum Therapeutics

A centralized repository with compliance integrated

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.

Aaron Froberg

Director of Global Infrastructure, Bio-Techne

Compliance, Collaboration, and Control

Life Sciences Regulatory Compliance

Meet Regulatory Compliance

Setting up a compliance envelope is easy to implement and manage with Egnyte. Streamline the administrative burden of managing your Quality process by leveraging advanced collaboration and compliance features. Audit trails track activity while GxP-compliant approval workflows enable digital document management and collaboration in a single interface.

Improve Collaboration

Supercharge collaboration on large files like SAS records, sequencing data, or DICOM imagery. Seamless integration with productivity and industry software streamlines collaboration on regulated content.

Seamless collaboration on large files like SAS records, sequencing data or DICOM imagery
  • GDPR
  • CCPA
  • New York Shield Act
  • UK’s DPA
  • Canada’s PIPEDA
  • China's Personal Information Specification
  • South Korea’s PIPA
  • Australia’s PPA

Protect Valuable Information

Detect sensitive information like PII and PHI to comply with data privacy regulations like GDPR and CCPA and monitors for threats like ransomware. Get alerted to misclassified sensitive data so you can prevent data breaches and theft of intellectual property.

Ramp Up Your Quality Process

In Egnyte for Life Sciences, your organization can manage the complete lifecycle of regulated documents with Part 11-compliant e-signatures.

Egnyte for Life Sciences Quality is a powerful tool that is tailor-made for emerging life sciences companies to meet FDA 21 CFR Part 11 regulations. Our features enable an effective quality management process by facilitating collaboration, complying with regulatory requirements, and reducing the administrative burden of maintaining quality documents. All of these capabilities are available in a unified, easy to use, and audit-ready GxP-compliant platform.

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Review and approval of controlled documents with Part 11-compliant e-signatures

Egnyte Makes Things Easier for Life Sciences

Prevent data breaches and theft of intellectual property

Exchange Data with External Partners

Managing regulated data in one place reduces administrative overhead and improves security. Granular permissions allow partners limited access to the platform while allowing oversight of project progress.

Securely collect data from CROs and sites

Retrieve and Organize Trial Data

Maintaining one repository for trial content eliminates data “hide and seek” and facilitates organization of a TMF. Securely collect data from CROs and sites through designated folders or password protected links. Harmonize your program’s metadata through tags so that you can align with the DIA reference model.

Handle Large File Formats

Handle Large File Formats

It’s the best of both worlds, the speed of working with a local file and the universal access of cloud content. The hybrid capability of our life sciences platform ensures the fastest performance while at the office coupled with real-time updates and secure remote access.

Tap into Advanced Cloud Services

Egnyte’s Public Cloud Connector is a simple way to sync data from Egnyte to public clouds, like AWS and Azure. Data can be automatically shared between Egnyte and your preferred compute environment for scientific processing, all without a single line of code.

GxP Audit Trails for FDA Compliance

Modern biotechs are moving compounds to the clinic at a faster pace than ever before. As a result, many companies struggle to ensure a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. Learn more about how the Egnyte for Life Sciences platform is designed to meet Part 11 requirements, like audit trails, versioning, and reporting.

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Egnyte for Life Sciences Advisory Board

Along with our customers, the Egnyte for Life Sciences Advisory Board shapes the future direction of our product. It is composed of world-renowned scientists, biotech venture capitalists, drug developers, and a Nobel laureate.

Meet the team

Praised By Egnyte Users
on G2

From a Single Platform, Egnyte for Life Sciences Enables

Additional Resources

ebook

GxP Buyer’s Guide

Read our buyer’s guide for a tangible framework to evaluate GxP solutions and ultimately, identify one or more that meet your specific needs.

White Paper

GxP Best Practices

Recent technological trends pose challenges for Quality & CSV teams. We’ve outlined best practices for tackling compliance issues when adopting new technologies.

eBook

Data Privacy Regulations Impacting the Life Sciences Industry

Data privacy laws around the world (CCPA, PIPA, APP) are harmonizing with GDPR’s principles-based approach. Are you ready?

Get Started with Egnyte Today