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. Egnyte gives you visibility and control over your most valuable asset—your data, all while adding a layer of regulatory compliance that doesn’t distract from the way you work.
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.
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.
We have streamlined the process for anyone in your organization to initiate, review, and approve controlled documents with Part 11 compliant e-signatures. Flexible enough to handle single- and multi-step workflows, designated stakeholders can collaborate on and approve regulated documents.