Steps Towards Digital Transformation in the Pharmaceutical Manufacturing Landscape Linking Data, Analytics, Knowledge and Risk
Foreword
“Connecting the dots to a Digital Future, Transitioning from Data to Informed Decisions”
Marcus O'Mahony and Anne Greene
Knowledge, Risk and Data
Steps Beyond Risk Assessment in QRM: RBDM, The next horizon
Valerie Mulholland, Anne Greene, and Martin J. Lipa
Deploying Analytics Solutions
“Deployment of Data Analytics to Support Manufacturing at Janssen”
Patrick T. O'Sullivan and Marcus O'Mahony
“Gaining Organisational Acceptance of a Data Analytics Programme in Eli Lilly”
Anthony Maguire and Marcus O'Mahony
“Data Architecture for Pharmaceutical Product Development at Alkermes”
Peter Couture, Damon Warnock, and Marcus O'Mahony
“Transitioning organisations from a data quagmire to knowledge nirvana through the digital thread”
David Twohig and Barry Heavey
Eliminating paper-based processes during manufacturing with a fit-for-purpose digital tool
Andrius Ramanauskas
Regulation, Data, and the Patient
“Holistic Risk-based Site Surveillance – A Data-based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical Industry”
Matteo Bernasconi, Thomas Friedli, and Nuala Calnan (editor)