Why Technology and Security Can’t Be Afterthoughts in Pharma Content Authoring
In life sciences, content systems aren’t just productivity tools—they’re subject to scrutiny from regulators, auditors, and internal validation teams. That means your structured content platform must deliver more than usability.
It must deliver:
- Compliance with GxP validation requirements
- Protection of proprietary product and safety data
- Secure, role-based access for distributed teams
- Transparent audit trails for every action taken
- Compatibility with IT security and quality controls
Docuvera was built to meet these standards from the start. Our platform combines secure cloud infrastructure, configurable controls, and built-in validation alignment—so you don’t have to choose between innovation and compliance.
How Docuvera Supports Security, Validation & Enterprise IT Requirements
Docuvera is a multi-tenant, SaaS platform deployed in secure cloud environments with region-specific hosting options and end-to-end encryption.
Secure Cloud Infrastructure
Docuvera is hosted on ISO 27001- and SOC 2-certified cloud platforms with built-in redundancy, encryption at rest and in transit, and real-time uptime monitoring—ensuring data security, availability, and resilience at scale.
Role-Based Access Control (RBAC)
Granular, configurable permissions allow you to manage access by user, team, content type, or function—enabling least-privilege access and aligning roles with GxP-compliant user categories.
Comprehensive Audit Trails
Every action—authoring, editing, reviewing, or publishing—is logged by user and timestamped. These detailed, tamper-evident records support both internal quality assurance and regulatory inspection readiness.
Validation Alignment
Built for validated environments, Docuvera supports configurable workflows and includes documentation and vendor support to meet 21 CFR Part 11, Annex 11, and broader GxP validation requirements.
Standards & Certifications
Docuvera’s infrastructure and controls support compliance with:
- 21 CFR Part 11: Electronic signatures, audit trails, and record integrity
- EU Annex 11: Computerized system validation and operational controls
- ISO 27001 & SOC 2 Standards: Security, availability, and confidentiality
- GxP Requirements: Designed for use in GMP, GLP, and GCP environments
We provide documentation, test evidence, and support to assist clients in meeting their IT, QA, and validation requirements during onboarding and system qualification.
Integration and IT Collaboration
Docuvera is built to integrate into the broader enterprise stack.
We support:
- Single Sign-On (SSO) with SAML 2.0
- API Access for integration with document management, RIM, and quality systems
- Enterprise-wide Oversight Rules covering audit trails, version control, and role-based access for greater technical accuracy
We work with your IT and compliance stakeholders to support implementation, qualification, and continuous operations. As documentation evolves from static files to structured content ecosystems, Docuvera enables organizations to keep pace with regulatory change while maintaining oversight and trust.
For more information, visit our trust center.