Knowledge & Risk Management Platform Deployment Across Global Network
The Challenge
A fast-growing biotech was experiencing significant knowledge loss during technology transfers from R&D to commercial manufacturing and between sites. Critical process knowledge existed only in the minds of key personnel, creating unacceptable risk.
Our Solution
Light Pharma implemented its proprietary e-KM and e-QRM platforms to create a unified knowledge and risk management ecosystem across the organization, capturing and making accessible critical process and product knowledge.
Our Approach
ICH Q9/Q10 gap assessment across all sites
Platform configuration and enterprise integration
Knowledge repository development with structured capture workflows
Risk management workflow implementation aligned to ICH Q9
Results
More Case Studies
Right-First-Time Manufacturing Through QbD & Investigations
Zero Critical Findings at Subsequent FDA Inspection
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