Review and Approve Part 11-Compliant Regulated Documents with Egnyte

Life sciences teams are more decentralized than ever, yet the need for speed persists. Even before the pandemic, the ability to bring together quality, clinical, and regulatory personnel to hit project timelines is what separated successful projects from those that languished. The pandemic added another barrier to an already complex venture.

Egnyte is meeting this challenge head-on by expanding its remote collaboration features for our life sciences customers with support for Part 11-compliant review and approval workflows that enable the management of regulated documents. Our GxP-compliant workflows streamline the review and approval process, removing bottlenecks for your regulated business processes and providing a single, compliant environment for designated stakeholders to collaborate on and approve regulated documents. This new expansion makes it easy for anyone in your organization to initiate and track the review and approval of controlled documents with Part 11-compliant e-signatures.

See it in action:

GxP-compliant Workflows with Egnyte for Life Sciences

Collaboration, Compliance, and Control:

• Flexibility and scalability: Whether you have a single or multi-step approval process, Egnyte can accommodate your workflow.
• 21 CFR Part 11-compliant: Ensure GxP compliance with electronic signatures, granular user access control, detailed audit trails, and checksums for data integrity.
• Notifications and progress: Automated notifications remind assignees when a task needs to be completed, and you can use the centralized dashboard to track progress.

Egnyte for Life Sciences is a unified platform for life sciences documents and data. We provide software that helps companies maintain GxP compliance, securely share documents, and meet data-privacy (GDPR, CCPA) regulations. Customers benefit from a centralized location for valuable information, aggregating study data from the ever-increasing number of data sources. Egnyte puts you in control of the compliance envelopes, retention policies, security posture, and access profiles for your data, facilitating collaboration without sacrificing security. Combined with a compliance layer that enables rapid validation, Egnyte for Life Sciences reduces the complexity of managing regulated data.

To learn how to activate review and approval workflows on your domain, contact us.

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