The Content
Cloud for
Life Sciences

Egnyte is purpose-built for GxP-regulated environments, with 21 CFR Part 11-compliant electronic signatures, automated document versioning, and audit trails that log every file access, edit, and share across all users and actions. The platform maintains inspection-ready documentation for all GxP customers and supports a continuously validated state — so regulatory readiness is operational, not a pre-audit scramble.

Egnyte's eTMF workspace aligns with CDISC models, tracks milestone completeness, and centralizes trial content across sponsors, CROs, and sites. Sponsors control access to case report forms, study files, and master documentation through role-based permissions and watermarked external sharing — while full audit trails trace every action throughout the trial lifecycle, supporting inspection readiness at any phase.

Egnyte enables governed external collaboration through watermarking, role-based access controls, and audit-ready sharing workflows that restrict partners to exactly the content they need. CROs, CDMOs, sites, and vendors get secure access without exposing sponsor IP, patient data, or proprietary research — and all external file activity remains within the sponsor's governance boundary, fully traceable.

Egnyte secures R&D content through granular permissions that restrict access by role, site, or external partner. Statistical computing files, clinical data vaults, and proprietary research are stored in a centralized secure repository, with anomaly detection that flags unusual access patterns in real time. Watermarking and encryption protect IP when files are shared outside the organization during partner collaboration or licensing discussions.

Egnyte supports FDA 21 CFR Part 11 and EU Annex 11 for electronic records and signatures, ICH E6(R3) for GCP, GxP requirements across clinical and quality operations, and HIPAA for patient data protection. Compliance controls — audit trails, version control, controlled document workflows with multi-stage review and approval — are built into the platform by design, not added as a separate compliance layer.

Egnyte maintains audit readiness as a baseline — not a deadline-driven event. Detailed audit trails track every document touchpoint across all users, automated workflows enforce SOP lifecycles to meet GxP and inspection requirements, and version control ensures teams always work from the latest validated document version. When auditors arrive, the record is already complete and immediately accessible.

Yes. Egnyte's AI includes AI Safeguards that give IT administrators policy-level controls over which content AI tools can access — preventing sensitive or regulated content from entering external AI systems. AI-powered classification automatically tags and routes incoming documents, applying permissions and triggering compliant workflows, without manual effort. This makes governed AI adoption practical in regulated life sciences environments where data integrity and control are non-negotiable.