Automated Batch Record Processing for Pharma and Biotech

Continued Process Verification (CPV) is the assemblage and evaluation of end-to-end production elements and processes data to guarantee the output of the product. FDA published a report in 2011, demarcating best practices for validating business processes in the pharmaceutical industry. In this report, CPV is outlined as the 3rd stage in process validation.

The main objective is to guarantee that all business processes are in a constant control state and hence guaranteeing the quality of the final product. The standard procedure of data collection is crucial for the effective implementation of CPV. For ensuring process consistency and capability it is essential that data must permit statistical analysis and trend analysis.

CPV Automation solution is a hybridization of AI and human intervention for digitizing 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.