Comprehensive Stability Reporting Capabilities
Automated Stability Tables
Generate comprehensive stability tables with automated data consolidation from multiple LIMS sources, ensuring data integrity and regulatory compliance throughout the process.
ICH Q1E Shelf-Life Calculations
Automated shelf-life determination following ICH Q1E guidelines, with comprehensive statistical modeling and confidence interval calculations for regulatory submissions.
Customizable Report Templates
Configure templates for different purposes – from initial approval to ongoing stability studies, PQRs, APRs, and ad-hoc trending reports.
Statistical Trend Analysis
Built-in sophisticated statistical analyses eliminate the need for external programs, providing shelf-life calculations and trend analysis with validated algorithms.
Certificates of Analysis Integration
Seamlessly integrate CoA data with stability reporting, ensuring complete traceability and supporting documentation for regulatory compliance.
Submission-Ready Output
Transform stability data into submission-ready documentation at the touch of a button, meeting all regulatory authority requirements.
Automated Stability Tables
Generate comprehensive stability tables with automated data consolidation from multiple LIMS sources, ensuring data integrity and regulatory compliance throughout the process.
ICH Q1E Shelf-Life Calculations
Automated shelf-life determination following ICH Q1E guidelines, with comprehensive statistical modeling and confidence interval calculations for regulatory submissions.
Customizable Report Templates
Configure templates for different purposes – from initial approval to ongoing stability studies, PQRs, APRs, and ad-hoc trending reports.
Statistical Trend Analysis
Built-in sophisticated statistical analyses eliminate the need for external programs, providing shelf-life calculations and trend analysis with validated algorithms.
Certificates of Analysis Integration
Seamlessly integrate CoA data with stability reporting, ensuring complete traceability and supporting documentation for regulatory compliance.
Submission-Ready Output
Transform stability data into submission-ready documentation at the touch of a button, meeting all regulatory authority requirements.
With over two decades of expertise in pharmaceutical quality processes, StudyGen 360 has become the trusted stability reporting partner for QC and CMC departments across leading pharmaceutical companies worldwide. Our platform delivers comprehensive automated solutions specifically designed for ICH-compliant stability studies, transforming manual reporting workflows into submission-ready documentation within minutes.
Key Features
Intelligent Issue Resolution
Automatically identify and address critical issues during report generation including unknown impurities, parameter spelling errors, changed method definitions, and country-specific product specifications with intelligent mapping solutions.
Comprehensive tracking of all laboratory activities with tamper-evident documentation.
Your Journey Starts Here
Ready to transform your clinical trials data management?
Experience the power of StudyGen 360’s integrated platform.
Scalable Solution for Any Lab Size
Whether you’re a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Learn more here!
Your Journey Starts Here
Ready to transform your clinical trials data management?
Experience the power of StudyGen 360’s integrated platform.
Scalable Solution for Any Lab Size
Whether you’re a small research lab or a large pharmaceutical company, StudyGen 360 scales with your needs. Learn more here!