
SWIS™ Analyze is built to transform complex assay outputs into validated, traceable and audit-ready results, it applies configurable rule sets, supports multi-marker logic, integrates real-time QC tracking, and ensures full compliance across regulated results.
The intelligent interpretation engine of the SWIS platform
Whether you're running simple tests or high-multiplex diagnostics workflow, SWIS ANALYZE eliminates manual data review and accelerates decision-making delivering speed, reliability, and audit-ready FDA/IVDR outcomes.
Key features
Robust data ingestion
- Rule-based interpretation aligned with assay design
- Multi-marker logic and complex clinical algorithms
- Fully configurable per assay and per customer requirements
Automated Data Interpretation
- Automated processing from raw data to final validated result
- Standardized pipelines across assays
- Elimination of manual interpretation variability
Integrated Quality Control
- Real-time validation of controls (positive, negative, internal)
- Automated QC enforcement before result release
- Built-in compliance mechanisms
Full Traceability & Auditability
- Complete tracking of: raw data, processing steps, decision logic
- Version-controlled pipelines
- Audit-ready outputs (FDA / IVDR aligned)
Analysis Pipeline
Implementation Process
Five-Step Integration
Assay Definition
Customer provides assay specifications
Pipeline Configuration
Repado configures the analysis pipeline and integrates customer-defined rules
Pipeline Verification
Repado verifies correct implementation and execution of the configured pipeline
Analytical Validation
Customer performs analytical validation of the assay and associated interpretation
Release to Market
Assay pipeline released for IVD/FDA use
Key Benefits
Speed
Eliminates manual review
Reliability
Deterministic and reproducible results
Compliance
Designed for regulated environments
(FDA, IVDR, 21 CFR Part 11, GLP)
Traceability
Full audit trail of every decision
Flexibility
Configurable for any assay
Scalability
From single assays to high-multiplex workflows

