A global pharmaceutical leader faced inefficiencies in its product release process due to reliance on manual workflows.
Site visits and paper records slowed release cycles and introduced costly GDP (Good Documentation Practice) deviations. Delays in change control reviews further extended hold times for site lots, sometimes by years. Human error, erroneous releases, and lack of real-time data visibility hampered compliance and operational performance, directly affecting the company’s bottom line.
Manual processes contribute to GDP errors and lengthy deviations. When deviations range from $5,000 to $15,000 each, and CAPAs range from $5,000 to $20,000 each, those costs add up fast and slow down your processes.
USDM’s Approach
USDM implemented ProcessX, its GxP-ready digital transformation platform, combined with intelligent workflows and automated validation capabilities tailored for the customer’s operational needs. Key focus areas included:
- Automating GMP workflow completion, review, and analysis.
- Implementing real-time data insights and analytics dashboards to track Product Hold and release metrics.
- Integrating AI-enabled trend analysis to predict potential risks and deviations before they occur.
- Streamlining change control processes for faster release cycles with Part 11-compliant electronic signatures and audit trails.
- Enhancing traceability and visibility of holds across the entire enterprise.
Measurable Business Impact
Time Savings: The company eliminated 2,100 hours of manual work annually at each of its 32 sites, totaling 67,200 hours saved per year.
Cost Reduction: With deviations costing $5,000 to $15,000 each and CAPAs ranging from $5,000 to $20,000, automation significantly reduced these risks, saving millions in operational costs.
Enhanced Compliance: The intelligent workflows ensured audit readiness and reduced high-risk deviations such as erroneous releases.
Improved Efficiency: The digital quality process decreased release cycle times, enabling faster time-to-market for critical products. Decision-makers now have real-time access to Product Hold data, improving response times and operational transparency.
Why USDM?
By combining regulatory expertise with future-ready GxP solutions, USDM delivers not just digitization but true process optimization. With intelligent automation, audit-ready compliance tools, and actionable insights, USDM is a trusted partner for life sciences organizations looking to transform their operations.
