Objectives

Pharmaceutical industry has consistently improved their manufacturing processes in compliance with good manufacturing practices. However, the deviation to good practices and falsification of medicines continue. In this context, SPuMoNI includes the following research questions:

  1. To what extent are current instruments and methods susceptible to falsified data and falsifiable data from multiple (big) pharmaceutical data streams?

  2. Under what circumstances can the integrity of critical pharmaceutical data assets be protected and verified in accordance to ALCOA guidelines and in compliance with EMA (European Medicines Agency) and FDA (U.S. Food and Drug Administration) regulations?

  3. To what extent can novel autonomous auditing and control mechanisms for data capture, governance and compliance be applied to pharmaceutical manufacturing contexts?

  4. Which characteristics of data artifacts can be used to precisely attribute the owner(s) (provenance) of that data, despite complex real-world and industrial scenarios?

  5. How effectively can data quality techniques ensure non-falsified data, non-falsifiable data, and detect random or systematic acquisition errors from multiple (big) manufacturing data streams

To address these research questions, SPuMoNI aims:

  • exploit and build on existing open software systems, frameworks and standards, such as OpenStack and Blockchain;

  • develop and evaluate quality control mechanisms for pharmaceutical data specifically with respect to hinder data falsifiability;

  • verify that security, privacy, compliance and ownership concerns have been properly met for the distributed, possibly open big data, that is processed and generated within pharmaceutical manufacturing contexts and environments;

  • intelligently control and coordinate data gathering, and processing within a plethora of contexts and environments;

  • demonstrate the applicability of the SPuMoNI technologies with respect to real-world manufacturing data and environments;

  • ensure the uptake of SPuMoNI technologies by engaging with relevant developer and user communities, including data scientists, and Industry 4.0 by producing a technology roadmap. 

  • pursuing other innovation and exploitation activities that aim to maximise market potential in the long term, including implementing an open data strategy to disseminate the project results.