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Life Sciences Data Management & Cloud Solutions

Compliance, Collaboration, Control: Streamlining the Development Process

Egnyte for Life Sciences is an industry-specific option on the Egnyte platform that enables companies to manage data, documents and governance in one place. Handle the ever-increased regulatory requirements with ease while avoiding tougher non-compliance penalties. Our cloud-based data management solutions allow life science organizations to experience faster and more secure collaboration with external partners like a CRO or CMO, consultants and providers as data sets have grown.

Comply With GxP and Part 11 Regulations

Comply With GxP and Part 11 Regulations

Teams that develop medicines, food and devices involved with human health, are expected to follow GxP, including compliance with FDA 21 CFR Part 11 or Annex 11. Egnyte for Life Sciences makes it easy to manage documents and data and follow these requirements through modern software, a validation package, and ongoing support to maintain compliance. Our life sciences cloud solutions integrate auditing, reporting, access controls, and robust governance to ensure that you are audit ready. Egnyte enables you to meet these regulations rapidly, inexpensively, and easily.

Secure Sensitive Data Across Repositories

Sensitive data is being generated and stored in numerous repositories in your organization - file servers and SharePoint, for example - and accessed by many external parties. This creates tremendous risk for you as data-privacy laws emerge (e.g. GDPR, CCPA, etc.). The Egnyte platform’s data protection and security capabilities for life science organizations help you manage those risks by monitoring access in real time, tracking sensitive data using machine learning, and mitigating security threats across numerous platforms and repositories.

Secure Sensitive Data Across Repositories

Exchange Data with External Partners

Exchanging data with external partners is essential to move development forward, but cumbersome technology limitations like FTP, VPNs and data silos add unnecessary complications.

Egnyte’s cloud-based solutions for the life sciences industry make it easy to exchange data like clinical study reports, batch records from a CMO, and facilitate clinical data management with less administrative overhead and greater security. Plus, granular permissions ensure that your data is firewalled such that only the right people have access to the right content.

Centralize Data From Lab Instrumentation

Data files such as imaging, sequencing and flow cytometry are measured in gigabytes and terabytes. With these data sets, cloud-only solutions have high latency and long wait times. The result is that scientists may be using outdated files, waiting to access data or struggling to share data with external partners.

Egnyte can centralize and cache large data files common in life science fields for use inside or outside your network. The hybrid capability of our life sciences data management ensures the fastest performance while at the office and secure access remotely as well.

Retrieve and Organize Trial Master Files (eTMFs)

Retrieving and securing your Trial Master Files is complicated and difficult to do when you have multiple programs and CROs.

Egnyte makes eTMF document management easy by providing a single Part 11 compliant repository. Our Trial Master File data management allows you to securely collect data from a CRO through folders or password-protected links. Further, you can harmonize your program’s metadata through our metadata tags so that you can align with the DIA reference model.

Additional information

GxP Feature Sheet

GxP Feature Sheet

Learn how Egnyte addresses GxP and 21 CFR Part 11 compliance for Life Sciences companies.

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Data Security Best Practices

Data Security Best Practices

Egnyte’s Governance Guru, Kris Lahiri, discusses his views on improving culture, processes, and technology for life science companies.

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Retrophin Success Story

Retrophin Success Story

Learn how Retrophin uses Egnyte to enhance governance, compliance and productivity.

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Discover and Control GxP Compliance Risks with a Complimentary Consultation

Learn how Egnyte for Life Sciences helps organizations become GxP compliant.

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