
Looking to upgrade your assay and instrumentation into a fully compliant IVD/FDA solution?
Are timelines and development costs delaying your market access?
SWIS™ is a modular, compliance-ready software platform that delivers tailored solutions across the complete workflow.
SWIS™ Software Packages
The software that brings your operational workflows together by enabling:
- Faster and error-free user interaction through step-by-step guidance
- Seamless integration with any type of device
- A branded, user-friendly GUI aligned with your identity
- Full control and visibility with real-time execution and monitoring
- Access to maintenance activities & historical data
Turn your data into reliable results with:
- Automated data interpretation for fast and consistent result generation
- Built-in decision logic aligned with your assay requirements
- Integrated quality and control checks to ensure result reliability
- Full traceability with review, approval, and audit-ready records
Wide spectrum of applications (ELISA, RT-PCR, dPCR, NGS, Luminex assays, Microarrays etc.)
Need more control? Create liquid handling protocols beyond the limitations of standard instrument software.
- Configure instrument, labware, layouts, pipetting parameters
- Build protocols using high-level pipetting functions (no code required)
- Execute complex liquid handling actions with precision and consistency
- Open integration of additional and external devices, without vendor or system limitations (PCR systems, multiplex platforms, etc)
Key Features
- Branded and customizable user interface aligned with the customer’s corporate identity
- User-friendly and guided operation that simplifies interaction and reduces user errors
- Adaptation to customer-specific operational workflows
- Seamless integration with liquid handling instruments and devices
- LIMS connectivity (HL7) and external system integration for data exchange and workflow automation
- Real-time execution monitoring and control with full visibility of process status and events
- Support of daily operations by providing access to maintenance tasks, system status, and historical data.
For the assay developer:
- Define and configure complex analysis pipelines with customizable, clinically validated rules
- Apply advanced processing logic to ensure data integrity from start to finish
- Apply configurable rule sets and multi-marker logic for accurate interpretation
- Validate and release clinical analysis pipelines for use in regulated environments
For the laboratories:
- Execute validated analysis pipelines with consistency and reduced user variability
- Review & approve validate results through controlled user workflows
- Maintain result integrity with real-time QC tracking and full traceability in regulated environments
- Manage inventory through kit registration and lot tracking
Define instrument configuration from scratch, including hardware, labware, and system setup
- Powerful editors for hardware and labware definition & integration
- Intuitive worktable layout design
- Support for multiple liquid classes enabling accurate and adaptable pipetting behavior
Flexible protocol development through a user-friendly method editor
Remote interface for external applications, enabling integration with third-party systems
Extendable architecture supporting new device integration and functionality expansion
Audit trail support, ensuring traceability of protocol configuration and execution changes
Regulatory & Lifecycle Support
Ensure long-term compliance beyond product delivery.
Post-commercialization regulatory surveillance to monitor compliance with evolving requirements
Ongoing compliance support to maintain alignment with standards such as IVDR, 21 CFR Part 11, GLP principles etc.
Change and update management ensuring that software updates remain compliant and fully documented
Audit and inspection readiness with support for documentation, traceability, and regulatory reviews

