CPV Batch Record Digitization:
Challenges and Role of AI

ABSTRACT

In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits. In spite of rising demand for the creation of digital data directly at the source itself, some companies follow the traditional methods of documenting the processes parameters on paper, on designed forms. This leads to data being inaccessible for others unless it is again digitized by someone. The traditional way of achieving this is to have someone enter the data into a computer system by shuffling around the pages in the document. The manual process consumes a lot of time and leaves very little time for the data entered to be validated. This article briefly describes the possible methods of automating the manual data entry process, and how the upcoming technologies can be used for this work.

Akash Gajbhiye

Lead Data Scientist,  Aventior Inc.


Akash Gajbhiye is the Lead Data Scientist at Aventior Inc. He is responsible for design, development and implementation of the Data Science and Artificial Intelligence based solutions. He currently leads all the Machine Learning and Deep Learning based solutions development, across various projects pertaining to Computer Vision and Automated Data Extraction technologies, and is involved in projects with some of the large Bio-Tech firms in the US and satellite operator companies in East-Asia.
Akash’s areas of research are in the computer vision and synthetic data generation domains. He comes from an interdisciplinary educational background in applied mathematics, with specialization in Mathematical Modelling and Simulation Development. In the past, he has worked with many R&D and heavy engineering organizations.

Abhijit Ray

CTO And Co-Founder, Aventior, Inc.


Abhijit is the CTO and co-founder of Aventior. With over 20 years in technology and working with some of the leading Biotech and Pharma companies, Abhijit has been instrumental is designing new AI solutions for process automation including document processing. Aventior’s solutions for Continued Process Verification and Data Management helps Biotech firms help decrease their efforts in data management, meta-data management and compliance.