Digital Quality Process Prevents Erroneous Releases and Avoids High-Risk Deviations

Discover more ways that automation dramatically improves cost savings, accuracy, and efficiency in GxP processes powered by ProcessX.

Manual processes contribute to Good Documentation Practice (GDP) errors and lengthy deviations. When deviations range from $5,000 to $15,000 each, and corrective and preventive actions (CAPAs) range from $5,000 to $20,000 each, those costs add up fast and slow down your processes.

Background

A prominent multinational pharmaceutical company faced significant challenges in their product release process. The company relied on time-consuming manual processes that included traveling to various sites and reviewing paper records to research and release products on hold. That also led to potential errors and delays. Change controls affecting site lots pending release could further delay product releases for weeks or years. Human error, Good Documentation Practice (GDP) deviations, and the erroneous release of products significantly impacted the company’s bottom line.

Approach

ProcessX, a GxP automation platform from USDM, proposed a comprehensive digital transformation strategy to address these challenges. It automated and optimized the completion, review, and analysis of GMP workflows, which helped reduce deviations, improve traceability of active holds, and enable trend analysis.

Outcomes

The company saved 2,100 hours of manual work per year at 32 sites, which equates to 67,200 hours saved. By reducing high-risk deviations like erroneous releases, the company improved its compliance and release cycle time. Product Hold information is always at their fingertips.

ProcessX is not just about digitizing but making the digital quality process more efficient.

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