The Data Revolution in Pharma: How FHIR enables next level business outcomes for Quality, Manufacturing, and Regulatory

Up to 70% of pharma data comes from the CMC domain, yet most of it sits in disconnected systems. Manual reconciliation between RIM, LIMS, QMS, and ERP increases delays and compliance risks. Regulators and industry are moving toward structured, interoperable data exchange, and FHIR has emerged as the key enabler.  

By applying data interoperability standards like FHIR, organizations can automate manual workflows, auto-generate content, and establish a validated foundation for faster approvals and audit readiness. Companies that act now will gain a significant advantage in speed, compliance, and readiness for future automation. 

In the webinar we will show how pharmaceutical companies have begun to digitize their CMC domains: 

• A single, validated source of truth for product data 

• Seamless, automated flow of information across R&D, Regulatory, and Manufacturing 

• Reduced manual reconciliation between systems (RIM, QMS, LIMS, MES, SAP) 

• Greater agility when responding to regulators and market changes 

• An AI-ready foundation built on structured, compliant data 

The webinar will also cover: 

• How FHIR enables digitization and automation of CMC data 

• What regulators could expect from structured, interoperable data in the near future 

• Real examples of how leading companies are connecting their CMC landscape 

• Key steps to start your digital CMC journey – and scale it enterprise-wide 

Speakers: 

Craig Anderson, Director, Business Outcomes Delivery, Johnson & Johnson 

Kåre Hyttel, Director, NNIT 

Who is the webinar relevant for?  

This webinar is relevant for professionals working with regulatory, manufacturing, and quality data in pharmaceutical organizations looking to increase efficiency, strengthen compliance, and accelerate product release cycles through better data connectivity.