Automated Batch Record Processing for Pharma and Biotech

Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the FDA published a report outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in process validation. Its central purpose is to ensure that processes are in a constant state of control, thus ensuring final product quality.

Crucial in effective CPV implementation is an appropriate data collection procedure. Data must allow for statistical analytics and trend analysis of process consistency and capability.

Our CPV Automation solution is a combination of AI technology and human intervention to digitize batch records. It addresses the need to convert unstructured data (printed text and numbers, date fields, values, handwritten notes, signatures, etc.) into a standardized data format.

The use of the CPV automation solution has yielded over a 300% reduction in processing time for batch records and over 60% reduction in the total cost of ownership.