Following several mergers and acquisitions, a biopharmaceutical company had to manage diverse brands, multiple facilities for different drugs and an increasing amount of data from disparate online and offline sources. In this environment, process monitoring and trending for Continued Process Verification (CPV) were extremely laborious tasks requiring manual data compilation and contextualization resulting in 80% non-value added activities (e.g., the continuous streaming of data from online sources with no batch context). As these data spanned long timeframes, it was very resource-intensive (time, people, money) to establish the relevant time window. Individuals were not able to spend their time on the interpretation of data and improvements required by the business.
Also, the dashboard creation for risk assessment was a time-consuming process. It required further manual compilation of data from multiple sources and calculations. The multiple transcriptions of data and information introduced high potential for error. These monthly and quarterly dashboards required over 100 tables and charts in Excel and PowerPoint. As all data were manually transcribed for each product, site and Critical Quality Attribute (CQA), it would take as long as a month to prepare a single dashboard.
These inefficiencies resulted in higher costs while also making it difficult to provide affordable treatments for patients in need. The customer implemented BIOVIA Discoverant to access data from online and offline sources and to feed other systems with data. Discoverant is the customer’s automated manufacturing analytics tool for extracting and contextualizing data in support of the company’s digital science and manufacturing informatics strategies.