The Centralized Platform for Pharmaceutical Temperature Excursion Analysis
No hardware required. Uses existing logger exports. Decision support only — final disposition remains with Quality.
Structured, Audit-Ready Temperature Excursion Analysis Workflow
From product stability data to QA/QP disposition decision — in a controlled, traceable process.
Define Product & Stability Profile
Register the product with labeled storage conditions, packaging, and stability data. Optionally upload product stability data (CTD 3.2.P.8 stability documents or other product stability studies data) for AI extraction of key parameters.
Log Temperature Excursion & Investigation Data
Capture temperature data via manual entry or data logger data upload, including duration, min/max values, detection details, and initial investigation inputs.
Run AI-Based Scientific Analysis
Execute AI analysis to calculate MKT, evaluate stability budget impact, assess risk, and generate a scientifically grounded disposition recommendation.
Includes MKT (USP <1079.2>), stability budget analysis, and risk classification
Review, Collaborate & Control Workflow
Manage the excursion through controlled workflow states (Draft → Open → Analyzed → Closed).
Generate Audit-Ready Report & Decision
Produce structured reports with complete data traceability, scientific justification, and QA/QP-reviewed disposition decisions.
Define Product & Stability Profile
Register the product with labeled storage conditions, packaging, and stability data. Optionally upload product stability data (CTD 3.2.P.8 stability documents or other product stability studies data) for AI extraction of key parameters.
Log Temperature Excursion & Investigation Data
Capture temperature data via manual entry or data logger data upload, including duration, min/max values, detection details, and initial investigation inputs.
Run AI-Based Scientific Analysis
Execute AI analysis to calculate MKT, evaluate stability budget impact, assess risk, and generate a scientifically grounded disposition recommendation.
Includes MKT (USP <1079.2>), stability budget analysis, and risk classification
Review, Collaborate & Control Workflow
Manage the excursion through controlled workflow states (Draft → Open → Analyzed → Closed).
Generate Audit-Ready Report & Decision
Produce structured reports with complete data traceability, scientific justification, and QA/QP-reviewed disposition decisions.
Built on product-specific stability data, MKT methodology (USP <1079.2>), and risk-based assessment aligned with FDA, EMA, ICH, and GDP expectations.
AI-assisted scientific analysis with human QA/QP review and final disposition decision.
What Makes ExcursionAssess AI Different
Product-Specific Stability Intelligence
Analyses are grounded in your actual stability data, not generic temperature limits.
Quantitative Methodology
MKT and cumulative stability exposure calculated using pharmacopoeial principles.
Risk-Based Logic
Excursion severity analyzed by duration, magnitude, and contextual factors.
Quality-Controlled Workflow
Automated analysis with QA/QP review and documented final disposition.
Platform Capabilities
Excursion Intake & Data Capture
Capture excursion events with automatic logger file parsing or manual data entry. System records time-temperature profiles, batch identifiers, storage conditions, and transport context to support traceable analyses.
Product Stability Profiles
Define stability profiles using long-term, intermediate, and accelerated study data. Configure labeled storage conditions, Arrhenius parameters, and cumulative stability budgets per product or SKU.
Core Excursion Analysis Engine
Scientific Methodology
Arrhenius-based MKT calculations aligned with USP <1079.2> and ICH stability principles.
Stability Intelligence
Supports cumulative stability budget tracking across multiple excursions.
AI-Assisted Risk Classification
Risk severity analyzed using duration, magnitude, and context with transparent logic.
Human-in-the-Loop Quality Review
QA/QP retain final authority with full traceability and audit readiness.
Designed for Regulated Pharmaceutical Teams
Built to support cross-functional, audit-ready decision making.