From Process to Intelligence: Inside J&J’s BPM-Driven AI Transformation

Borke Van Belle has built a distinguished career at Johnson & Johnson, spanning over two decades, beginning in 1998. With a background as a Bio-engineer in Chemistry, he established his foundational expertise in Quality Assurance and the complex processes of pharmaceutical production. Having served in various leadership roles within J&J, his experience provides a deep, process-centric understanding of operational excellence. As the Senior Director and Head of R&D Quality Process & Data Management for Innovative Medicine, he now focuses on how Business Process Management (BPM) is enabling the organization to successfully scale new Artificial Intelligence (AI) solutions across the enterprise. His insights are vital to understanding the role of BPM in driving J&J’s ongoing digital transformation and AI implementation strategy. 

How has BPM enabled J&J to scale AI? 

Johnson & Johnson (J&J) is transforming its approach to process management, moving from traditional documentation methods to a more dynamic, AI-enabled BPM framework. This shift is not just a technology upgrade, it’s a strategic foundation for the company’s future. 

Historically, J&J maintained standard operating procedures (SOPs) in two places: as documents in a document management system and as process maps within a BPM tool. This created inefficiencies, as every procedural update had to be manually made in both places. 

To resolve this, J&J is adopting a single-source approach using the ARIS BPM tool. Rather than duplicating SOPs, the ARIS system now serves as the central repository for BPMN process maps, complete with their data and metadata. From this structured format, SOPs are automatically generated and published into the document management system. This transition marks a significant evolution from managing static documents to managing structured, reusable content.  With over 45,000 procedures in use across the company, J&J recognized the need for automation to digitize and structure its content. AI tools are being used to read and analyze existing SOPs, transforming them into BPMN-compliant process maps. This digitization allows J&J to integrate SOPs into a standardized, centralized system, laying the groundwork for advanced analytics, traceability and continuous improvement. 

What AI-specific benefits does BPM provide J&J? 

Operating in a highly regulated industry, J&J must comply with over 2,000 global regulations. This requires constantly reviewing updates to ensure compliance across its quality systems. 

To address this, the company has developed a solution that leverages large language models (LLMs) to compare regulatory content against internal process maps. This capability enables: 

• Gap analysis between new regulations and existing processes. 

• Heat maps to visualize where regulatory mismatches exist. 

• Suggested mitigations to bring processes back into compliance. 

Instead of manually reviewing thousands of pages of regulatory texts, J&J can now use AI to identify impact areas efficiently, ensuring proactive and accurate compliance. 

What role will BPM play in J&J’s ongoing AI implementation? 

Looking to the future, J&J plans to bring AI even closer to its employees. The vision includes a ChatGPT-style virtual assistant that enables staff across the organization to interact directly with the BPM system. By embedding AI at every step of the value chain, from authoring processes to consuming them, J&J is building a smart, responsive and user-centric quality management system. 

One of the most transformative AI applications J&J is investigating is the use of agentic AI, autonomous systems capable of performing complex tasks across systems. While these AI agents promise massive efficiency gains, they introduce new challenges: 

• How do you audit an AI agent’s actions? 
• How can AI decision-making remain explainable to regulators? 
• How do you maintain human oversight (“human in the loop”) in safety-critical processes? 

Regulatory frameworks like the EU AI Act as valuable guidance, highlighting the importance of transparency, accountability and explainability in AI deployments, particularly in life sciences. 

For J&J, this means designing AI systems that not only function effectively but are also traceable and verifiable, able to stand up to inspection by global health authorities. Another future-facing initiative involves bridging the gap between process design and real-world execution. Currently, J&J is optimizing and standardizing processes based on human workflows, but the next step is creating a closed-loop system where BPM is tightly connected to operational data. 

As J&J continues to evolve, its investment in structured, explainable and auditable processes will ensure that innovation is not only fast, but safe, compliant and sustainable.