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Next-Generation ECM Platform Modernization and Regulatory Compliance Expansion

sigma.software

Information technology

Government

Medical

Business Challenges

Need to rapidly scale development capacity while maintaining product quality and regulatory compliance across expanding market segments, including healthcare and government sectors with complex compliance requirements (GDPR, FDA CFR 21 Part 11, GAMP5). Existing development resources insufficient to meet aggressive growth targets while maintaining multiple product versions and compliance frameworks.

About the Client

Scandinavian enterprise content management (ECM) software vendor specializing in document management solutions for regulated industries

Strategic Goals

Establish long-term nearshore development partnership to triple product release velocity
Maintain and enhance compliance with evolving regulatory frameworks across multiple industries
Create specialized healthcare-focused ECM solution (Platina Life Science) with dedicated development team
Implement robust quality management system (QMS) compliant with pharmaceutical industry standards
Ensure 100% audit readiness for regulatory inspections in life science sector

Core System Requirements

Configurable document/case management workflows with audit trails
Collaborative document creation and approval tools
Regulatory compliance framework (SOX, ISO, GDPR, WCAG, FDA CFR 21 Part 11)
Healthcare-specific quality management modules
Multi-browser responsive UI with mobile access
Scalable architecture supporting 30K+ concurrent users
Preconfigured compliance dashboards and reporting tools

Technology Stack

.NET Framework

Cloud-native architecture

On-premise deployment options

BYOD environment compatibility

System Integrations

Existing QMS documentation systems
Pharmaceutical audit management platforms
Government information exchange protocols
Electronic signature validation systems

Performance Requirements

Support for 40 million+ document repository
High-availability architecture with 99.99% uptime
Role-based access control with patient data protection
Multi-tenancy support for cloud deployments
Automated compliance validation workflows

Business Outcomes

Establish Formpipe as market leader in Swedish ECM sector with 80% government adoption, successfully penetrate pharmaceutical market with compliant Life Science solution, reduce time-to-market for regulatory updates by 60%, and maintain 100% audit compliance across all regulated industries through dedicated development and QMS teams.