Security & Compliance
Built for regulated pharmaceutical environments
Managed Access Programs operate in some of the world's most highly regulated environments.
From patient data and program governance to electronic records and audit readiness, pharmaceutical organisations need technology that supports compliance by design—not as an afterthought.
Maprium has been purpose-built to help BioPharma organisations manage global Managed Access Programs with confidence, combining enterprise-grade security, regulatory alignment and operational governance within a single platform.
Compliance by Design
Compliance is embedded throughout the Maprium platform, supporting regulated operational processes, data integrity and inspection readiness.
Our platform has been designed to align with recognised pharmaceutical and life sciences best practice, enabling organizations to implement Managed Access Programs with greater consistency, control and confidence.
Key capabilities include:
Information Security You Can Trust
Information security practices aligned with ISO/IEC 27001
Role-Based Access Control (RBAC) with granular permission management
Single Sign-On (SSO) integration and Multi-Factor Authentication (MFA)
Continuous security monitoring, vulnerability management and incident response processes
Encryption of data both in transit and at rest using industry-standard protocols
Secure software development and operational security practices
Maprium is designed with security-first practices across infrastructure,
application, and data layers.
Privacy & Data Protection
Maprium has been designed using privacy-by-design principles to support organizations operating across multiple regulatory jurisdictions.
The platform supports robust governance of personal and sensitive data throughout its lifecycle.
Capabilities include:
GDPR-aligned privacy and data protection architecture
Support for HIPAA security and privacy requirements where applicable
Configurable data retention and secure archiving policies
Secure data lifecycle management
Encryption and secure handling of sensitive information throughout processing and storage
Operational Governance
Effective Managed Access requires more than secure technology.
It requires robust operational governance.
Maprium provides built-in controls that help organizations standardize processes, strengthen oversight and maintain compliance throughout program delivery.
Governance capabilities include:
Operational processes aligned with ISO 9001 quality management principles
Controlled change management and release processes
Workflow approvals and segregation of duties
CAPA and deviation management support
Compliance dashboards providing real-time operational visibility
Periodic review tools supporting ongoing governance and user access reviews
Configurable data retention and archiving aligned with regulatory and contractual requirements
Our experts can help.
Enterprise Platform Reliability
Global Managed Access Programs depend on resilient technology. Maprium has been designed to provide the availability, scalability and operational continuity expected of enterprise pharmaceutical platforms.
Platform reliability includes:
Automated backup and disaster recovery processes
Secure cloud infrastructure supporting global program delivery
High-availability architecture designed for business continuity
Flexible regional hosting and data residency options to support country-specific regulatory requirements
Scalable multi-tenant architecture capable of supporting enterprise growth
Supporting Global Managed Access with Confidence
Security, compliance and governance are not separate features—they are foundational to the way Maprium is designed.
By combining enterprise-grade security, regulatory alignment and operational governance within a purpose-built Managed Access Operating System, Maprium enables pharmaceutical companies to manage increasingly complex global programs with confidence.
Whether supporting Quality teams, Medical Affairs, Compliance, IT or Executive Leadership, Maprium provides the controls, visibility and assurance needed to operate Managed Access as a strategic enterprise capability.
Want to Learn More?
Our team can provide additional information on platform security, validation, compliance documentation and deployment options to support your internal quality, procurement and IT review processes.
Take a personalized 15-minute tour
To request a demo, discuss your access challenges or learn more about Maprium, please use the secure form.