A Validated Hosting Environment for Matrix eIFU
A fully validated architecture and hosting environment built for GxP compliance, data integrity, and the regulatory expectations of EU MDR, FDA 21 CFR Part 11, and ISO 13485.
For taking a demo with our team.
The challenge
Computer system validation is not optional — and it's expensive to build yourself
- CSV is a regulatory expectationUsing a non-validated or generic system for eIFU creates significant compliance risk.
- Internal validation takes monthsBuilding a validated environment from scratch consumes significant internal resource.
- Security expectations keep risingNotified bodies increasingly scrutinise the security and resilience of eIFU hosting.
Our solution
A ready-to-use, pre-validated environment backed by full documentation
- 21 CFR Part 11 compliantApplication features and controls aligned to FDA electronic records requirements.
- GAMP 5 aligned validationA category-aligned software validation approach, with a ready CSV blueprint.
- ISO 27001 aligned securityRegular penetration testing, vulnerability assessments, and EU-based data residency.
Core capabilities
A pre-validated environment that removes months of internal validation effort.
Regulatory-aligned compliance
Built to meet 21 CFR Part 11, GAMP 5, and ISO 13485 expectations from day one.
21 CFR Part 11 compliant application features
GAMP 5 category aligned software validation approach
Computer system validation blueprint and guidance
Enterprise-grade security
Information security controls aligned to ISO 27001, tested regularly.
ISO 27001 aligned information security controls
Regular penetration testing and vulnerability assessments
EU based data residency
Resilient by design
Built to keep your eIFU content available when it matters most.
Disaster recovery and business continuity protocols
Months of internal validation effort saved
Reduced notified body audit risk
Hear from our customers
