How a CDMO Gained 40%+ Efficiency by Generating Automated Annual PQRs

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The Problem

One of our CDMO clients found themselves experiencing longer and longer cycle times for complete batch release reports and submerged in an overwhelming tide of over 350 product quality review (PQR) reports annually, a number that was only on the rise. The manual compilation of all these reports, crucial for ensuring product quality and compliance, had become a Herculean task. The process involved laboriously gathering data from a disparate set of systems, including Trackwise QMS, SAP, a multitude of Excel spreadsheets, and a process historian–further complicated by activities and resources being spread across 3 physical manufacturing sites. This manual method not only consumed vast amounts of time but also bogged down their operational efficiency.

The Solution

In response to our Client's mounting challenges with manual PQR processes, we introduced Aizon Unify: a cloud-based next-generation historian designed to streamline data management. Aizon Unify stands out by its capacity to seamlessly integrate disparate data sources, across time-series process data as well as structured data–transforming raw data into cohesive, contextualized dashboards. This integration not only facilitates the aggregation of data across platforms but also enhances real-time and historical data visibility, bringing unprecedented efficiency to every team in our Client's operations.

The Impact

The impact of deploying Aizon Unify has been nothing short of transformative. Efficiency grew by 40%, also revolutionizing the way our Client approaches audits. The cumbersome task of manually generating reports for audit compliance has been replaced by an automated system that effortlessly produces standard reports. The addition of Aizon Unify also seamlessly pulls data from multiple sources without the need to chase people down to meet deadlines. These reports outline batch results, setting them against expected thresholds and providing comprehensive insights into details, changes, deviations, testing, and conclusions.

This breakthrough solution has propelled our Client into a new era of audit-readiness, where navigating through audits becomes a seamless journey rather than an uphill battle. The adoption of Aizon Unify has not just optimized their operational efficiency; it has redefined it, ensuring that they are not just keeping pace but setting the pace in an increasingly competitive and regulated environment.

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