Digitization of batch records – automated & accelerated
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Continued Process Verification CPV-AutoTM
For pharma manufacturers, automation of batch records has become a priority. However, given the requirements around strict compliance and lack of automation tech, the collection of production parameters happens to be manual, where data is still collected and printed (sometimes even handwritten) on paper batch records. It poses a big challenge for quality, CMC, and MS&T. The objective of the CPV-AutoTM platform is to automate the process of data collection, processing, storage, and analysis thereby, offering near real-time access to CPP for quicker decision making.
Understanding CPV-AutoTM
CPV-AutoTM solution we create is essentially a cloud-based SaaS platform. It’s highly secured and is 21 CFR Part 11 compliant. It is used to automate the process of digitizing paper batch records. It has a sophisticated and complex AI engine that uses some of the latest techs in OCR, text analytics, and image processing. This is then used to identify and extract critical production parameters (CPP) from paper batch records.
CPV-AutoTM Workflow
The platform automates the manual process of monotonous and error-prone documentation of the CMO batch records.
It digitizes paper batch records into a structured format, i.e., printed text and numbers, date fields, values, handwritten notes, signatures, etc. into a standard name-value data structure.
Figures supporting the automation benefits
Over 66% reduction in processing time for batch records
Over 60% reduction in the total cost of ownership
