Light Pharma Automated Intelligence
Revolutionizing OOS / OOT Investigations
Investigating Out-of-Specification (OOS) or Out-of-Trend (OOT) results is time-consuming and resource-intensive. Light Pharma Automated Intelligence streamlines initial analysis, centralizes data, provides actionable insights, and supports compliance - transforming complex investigations into efficient processes.
Centralized Data Repository
Seamless Integration
Integrates with LIMS, ERP (SAP, Oracle, etc.), TrackWise, and EDMS to unify data across multiple sources.
Centralized Access
Access batch information, materials, analytical methods, and process data in one place.
Real-Time Visibility
Monitor OOS/OOT trends, deviations, and investigation details as they happen.
Continued Process Monitoring
Continuous assessment of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) ensures proactive risk identification and process optimization.
Process Capability
Ongoing evaluation for newly manufactured batches using Ppk and Cpk metrics.
Advanced Visualization
SPC charts, histograms, X-bar/R charts, and capability analysis graphs.
Automated Intelligence Reports
Initiate Reports
Start directly from batches with OOS/OOT parameters for immediate analysis.
Analyze Historical Data
Review the last 25 batches to detect trends and anomalies, with flexibility to add earlier batches.
Generate Insights
Use Anderson-Darling plots, Grubbs outlier tests, and SPC charts for comprehensive analysis.
Advanced Data Analysis Tools
Visualize data trends with SPC outliers, shifts, drifts, and capability analysis. Perform correlation analyses using scatterplots to assess relationships between attributes and identify root causes.
SPC Charts
Detect outliers, shifts, drifts, and run rule violations.
Capability Analysis
Cpk/Ppk metrics with confidence intervals and visual capability graphs.
Correlation Analysis
Scatterplots to assess relationships between attributes and root causes.
Outlier Detection
Anderson-Darling and Grubbs tests for rigorous outlier identification.
AI-Augmented Summaries & Conclusions
Intelligent Automation
AI-driven summaries and recommendations based on comprehensive data analysis, with human override capabilities for critical decisions.
Advanced Correlation
View correlated attributes and parameters with predefined thresholds. Integrates with heat map tools for attribute-parameter relationships.
Streamlined Workflow & Compliance
Seamless progression from batch selection to report generation, with built-in comment capture and transparent tracking.
E-Signatures
21 CFR Part 11 compliant e-signatures at all stages.
Audit Trails
Complete tracking of changes and approvals for inspection readiness.
Data Security
Embedded compliance with CGMP and EU Annex 11 standards.
Light Pharma Automated Intelligence In Action
See how Light Pharma Automated Intelligence transforms OOS / OOT investigations - from automated workflow to AI-driven correlation analysis.
Streamlined Investigation Workflow
Seamless progression from batch selection to report generation with built-in comment capture and transparent tracking.
Automated Intelligence Reports
Start from batches with OOS/OOT parameters, analyze the last 25 batches, and generate insights using Anderson-Darling, Grubbs, and SPC.
AI-Augmented Conclusions
AI-driven summaries and recommendations based on comprehensive data analysis - with human override for critical decisions.
Advanced Correlation Analysis
View correlated attributes and parameters with predefined thresholds, integrated with heat map tools to identify root causes.
The Light Pharma Automated Intelligence Advantage
Reduce Timelines
Minimize manual effort and accelerate investigation processes.
Enhance Quality
Improve process reliability and product quality through data-driven insights.
Ensure Compliance
Maintain regulatory readiness with embedded compliance features.
Drive Improvement
Gain actionable insights for continuous operational excellence.
Frequently Asked Questions
What is Light Pharma Automated Intelligence?
It is a compliance-driven automation platform that streamlines OOS (Out-of-Specification) and OOT (Out-of-Trend) investigations. It centralizes data, automatically reviews historical batches, applies statistical tests (Anderson-Darling, Grubbs, SPC), and uses generative AI to draft summaries and recommendations.
How does it integrate with our existing systems?
Light Pharma Automated Intelligence integrates with LIMS, ERP (SAP, Oracle, Microsoft Dynamics), TrackWise, and EDMS - pulling batch information, materials, analytical methods, and process data into one centralized repository.
What statistical tools does it include?
SPC charts (with outlier, shift, drift, and run-rule detection), Cpk/Ppk capability analysis, Anderson-Darling plots, Grubbs outlier tests, X-bar/R charts, histograms, correlation scatterplots, and heat maps.
How does the AI work, and is it auditable?
Generative AI creates summaries and recommendations from your investigation data. Every AI output is logged in an audit trail and can be overridden by a human reviewer. Final reports always carry a human approval.
How does it handle compliance?
21 CFR Part 11 e-signatures at every stage, complete audit trails of all activities and approvals, embedded compliance with CGMP and EU Annex 11, and exportable change histories for inspection readiness.
Ready to See It in Action?
Book a 30-minute live demo. We will walk through your data, your workflow, and your compliance requirements - whatever matters most to your team.
Or copy our address: support@lightpharma.com · we usually reply within one business day.