OpenBECS

One platform that adapts to regulations worldwide.

• Multi-regional compliance engine - Simultaneously operate under FDA, EMA, Health Canada, and other international standards
• Country-specific workflows - Automatically apply local regulatory requirements based on facility location
• Built-in regulations library - Always up-to-date database of global plasma and blood banking standards and requirements
• Regulatory change notifications - Automated alerts when regulations are updated in your operating regions
• Cross-border operations - Seamlessly manage facilities across multiple countries from a single system
• Localized documentation - Generate region-appropriate forms, labels, and reports automatically

Your quality system and audit preparation in one unified platform.

• End-to-end traceability - Complete donor-to-product audit trail with immutable records
• Quality management system (QMS) - Built-in CAPA, deviation management, and quality metrics tracking
• One-click audit reports - Generate comprehensive compliance reports for regulatory inspections
• Risk management tools - Automated risk assessments and mitigation tracking
• Document control - Version-controlled SOPs, work instructions, and quality manuals
• Audit trail protection - Tamper-proof records with digital signatures and timestamps
• Regulatory submission support - Export data in formats required by health authorities

Empower your team with integrated learning and development.

• Production environment training - Safe training mode using segregated data in your live system
• Role-based training modules - Customized learning paths for different positions and experience levels
• Competency tracking - Monitor staff qualifications, certifications, and training completion
• Standard operating procedures (SOPs) - Integrated access to current procedures within workflows
• Knowledge base - Searchable repository of policies, procedures, and regulatory guidance
• Training compliance reporting - Demonstrate staff competency for regulatory inspections

Streamline operations with intelligent automation and AI.

• AI-powered configuration - Intelligent setup assistance and workflow optimization
• Automated validation testing - Continuous system verification and compliance checking
• Smart alerts and notifications - Proactive monitoring for expiration dates, equipment maintenance, and compliance deadlines
• Workflow automation - Reduce manual tasks with configurable business rules
• Performance analytics - Real-time dashboards and KPI tracking for operational insights
• Predictive maintenance - AI-driven equipment monitoring and maintenance scheduling

Flexible, scalable platform that grows with your organization.

• One-click environment migration - Seamlessly move configurations and data between test, staging, and production
• Acquisition support - Easily integrate new facilities when buying or selling plasma centers
• API and webhook integration - Connect with LIMS, ERP, accounting, and other external systems
• Multi-language support - Per-user language preferences supporting global teams
• Scalable architecture - From single centers to multi-national operations
• Cloud, on-premises, or hybrid deployment - Choose the hosting model that fits your needs

Maximum impact with minimal complexity.

• Intuitive user interface - Clean, modern design that reduces training time
• Streamlined workflows - Purpose-built screens that guide users through complex processes
• Consolidated data model - All information accessible from a handful of well-designed screens
• Mobile-responsive design - Full functionality on tablets and smartphones
• Single source of truth - Eliminate data silos and duplicate entry
• Quick implementation - Get operational faster with pre-configured industry templates

Bank-level security protecting your most sensitive data.

• HIPAA/GDPR compliance - Built-in privacy protections and data governance
• Role-based access control - Granular permissions ensuring users see only what they need
• Data encryption - At-rest and in-transit protection for all sensitive information
• Audit logging - Complete user activity tracking for security and compliance
• Backup and disaster recovery - Automated data protection and business continuity
• Single sign-on (SSO) - Integration with enterprise identity management systems