Towards a Computational Approach for the Assessment of Compliance of ALCOA+ Principles in Pharma Industry.

The pharmaceutical industry is a data-intensive environment and a heavily-regulated sector, where exhaustive audits and inspections are performed to ensure the safety of drugs. In this context, processing and evaluating the data generated in the manufacturing lines is a relevant challenge since it requires compliance with pharma regulations. This work combines data integrity metrics and blockchain technology to evaluate the compliance-degree of ALCOA+ principles among different levels of drug manufacturing data. We propose the DIALCOA tool, a software to assess the compliance-degree for each ALCOA+ principle, based on the assessment of data from manufacturing batch reports and its different levels of information.