Case Study

Simplifying CPV Validation And Consistency

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This BIOVIA customer is one of the leading organizations in small molecule therapies, covering a wide range of therapeutic areas from pain management to cancer treatments. The organization’s R&D and manufacturing sites span multiple continents, with headquarters in the US and Europe. Maintaining such a diverse portfolio across various geographic areas is a challenge for any company, yet the manufacturing team has consistently performed among the most compliant groups in the industry. As pressure from the FDA increases for firms to thoroughly adopt Continued Process Verification (CPV) in their manufacturing operations, this customer’s leadership decided to proactively seek out a tool to maintain their spot at the front of the pack.

The main challenge facing the leadership team in ensuring consistent CPV initiatives across their different manufacturing sites was maintaining a uniform standard of data in their manufacturing analytics. Different sites utilized different siloed systems, and this data disconnect made validating processes and analyses difficult and time consuming. Additionally, variations in how the data was queried from these systems often led to different interpretations, further extending investigations and reporting. As a result, the leadership team sought a system that could facilitate enterprise-wide data continuity while simultaneously ensuring consistent methodologies for data querying and analysis.

Read how BIOVIA Discoverant’s software infrastructure, purpose-built for biopharmaceutical manufacturing, was the solution.

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