GxP Compliance
Data integrity, quality and compliance with FDA 21 CFR Part 11.
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GxP Compliance for Emerging Biotech
From managing regulated documents to ensuring data integrity, Egnyte is the easiest way for emerging biotechs to get over the compliance hurdle. Effective and efficient clinical data management gets you to trial completion faster.
Speed to Patient
Achieve rapid validation without slowing down the pace of innovation.
Unified Compliance
Facilitate management of regulatory and unregulated content with a single, centralized data repository.
Optimized Workflows
Increase process efficiency through automated review and approval workflows.
GxP Compliance Made Easy
21 CFR Part 11 Compliant
Comply with regulatory requirements when creating, storing and managing GxP-regulated documents. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance.
Easy to Implement & Manage
Establish a regulated environment accessible only to credentialed employees and external partners, whether your compliance envelope covers all your documents or just a single type. Use the compliance portal, as a central hub to facilitate auditing, validation, and reporting.
Ramp Up Your Quality Process
Enable an effective quality management process by facilitating collaboration, complying with regulatory requirements, and reducing the administrative burden of maintaining quality documents.
The Power of Many Solutions In One Turnkey Platform
GxP Enterprise Lite
- GxP Compliance Portal
- Audit Trails
- Multi-Step Workflows
- Data Lifecycle Management
GxP Enterprise
- GxP Compliance Portal
- Audit Trails
- Rapid Validation
- Content Safeguards
- Ransomware Detection & Recovery
Over 600 Life Sciences Customers Trust Egnyte
We are putting all documentation submitted to FDA and other regulatory agencies in Egnyte, so that now and in the future, people know where to find the actual documentation that was given to the agencies for review.
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 and sent to our cloud computing platform for processing.
See Egnyte GxP in Action
Egnyte for Life Sciences Streamlines GxP Compliance
- Validate systems with Part 11-compliant documents
- Automate regulated document management with multi-step review and approval
- Maintain audit-readiness with file versioning and audit trail reporting