FoRESight - Trusting & Using the Data

FoReSight: Trusting and Using the Information from Data Analytics to Support Decision-Making in Pharmaceutical Manufacturing

PMTC's FoRESight project led by Marcus O'Mahony, PhD was a Framework and Risk management methodology for the provenance of data transformations to support the use of data analytics for decision-making across pharma and biopharma manufacturing. This collaborative research project led by PMTC included Eli Lilly, MSD, Astellas, Janssen, Alkermes, and PRST.

Background: Data is not information. Information is actionable. Data, alone, is not. This distinction has significant risk management consequences when using data to support decision-making in the highly regulated pharma and biopharma manufacturing sector. A new framework is proposed to support the trustworthy use of the information generated from data, by data analytics, for effective risk-based decision-making. The emergence of a standardised approach for using such information is essential to avoid duplication and divergence of efforts across the sector. Ensuring that any proposed approach aligns with regulatory expectations for the sector is also essential.

The project established a framework and risk management methodology tool for the provenance of transformed data to better enable decision-making using data analytics tools across pharma/biopharma manufacturing.

Please find link below for further details -

https://arrow.tudublin.ie/japrs/vol1/iss1/8/