Generative AI (GenAI) is revolutionizing workflows across industries, and the pharmaceutical sector is no exception. At Santen Pharmaceutical, Brightly designed and implemented ChatAIRI, a generative AI tool that streamlines regulatory work. This solution enables experts to quickly retrieve critical compliance information, reducing time spent searching through regulatory data and enhancing operational efficiency.
Start with the Problem, Not the Technology
There's a popular narrative around AI that your future success depends on your organization's ability to adopt AI as fast as possible, before competitors do. This sense of urgency tends to overshadow a far more relevant perspective: your success with AI doesn't depend on how quickly you adopt it, but on how effectively you use it to solve the problems of your organization or customers.
Your unique competitive advantage stems not from adopting the latest technologies, but from your ability to solve your customers' business problems and build problem-solving capabilities within their organizations. This core principle drove our approach in Santen Pharmaceutical's case, as it does in all our projects. First, we identify the operational challenge we want to solve, then design and build the optimal solution.
In Santen's case, we focused on simplifying the workflow of the team responsible for global and market-specific pharmaceutical products serialization and traceability regulations. The team is responsible for implementing the national, EU-level, and global regulatory requirements aligned with the company’s strategic and business objectives. Other business functions also rely on the team’s expertise in meeting the regulatory compliance respectively. For example, the packaging artwork designers rely on these experts to ensure medicine packaging meet the traceability and legal compliance requirements in each market.
The key challenge was clear: experts spent excessive time searching through vast regulatory documents to answer queries – time that can be used for higher priority tasks. Santen wanted to validate whether an AI-based regulatory intelligence service could make their operations more efficient and productive.
Design GenAI Tools to Build on Current Ways of Working
Once we identified the key problems, we evaluated potential solutions. While AI could streamline many workflow stages, the core of the solution needed to focus on creating an effective service with AI-powered functionalities that enhanced existing processes.
We started concepting ChatAIRI by observing how the traceability regulation team worked, focusing on two key questions:
- Can we trust on AI’s responses or are there hallucinations?
- How we can make the service easy to use and intuitive?
The team's workflow consisted of three main steps:
- Receiving regulatory and legislative documents from the regulators and authorities
- Using their expertise to identify the information and intelligence needs across the organization
- Formulating answers based on these needs
Through user insights, we designed a solution that integrates seamlessly into the team's existing workflow. Understanding current ways of working proved crucial - only by understanding existing processes and actively involving users in designing their future way of working could we successfully manage organizational changes introduced through new tools.
Future-Proof AI Solution for Regulatory Compliance
Building on our understanding of user needs, we collaborated with Santen's team to implement a chat interface – an accessible approach capable of handling complex regulatory materials. ChatAIRI's architecture rests on three foundational pillars, each crucial for pharmaceutical compliance:
Intelligent Processing and Accuracy
Our document analysis system not only comprehends complex regulatory documents but ensures accuracy through multi-layered safeguards. Specialized prompting techniques force the GenAI model to adhere strictly to sources, while a recursive refinement process allows for iterative improvements – similar to how human experts verify and refine their answers.
Transparent and Traceable
Every response includes an interactive citation system with direct references to source documents. This transparency enables quick verification and builds user trust – essential features in regulatory compliance work. For Santen's team, this translated into faster response times, improved compliance knowledge, and more efficient use of expert resources.
Future-Ready Architecture
Instead of building for current AI limitations, we designed ChatAIRI to be model-agnostic. This flexible architecture adapts to improvements in AI technology without requiring fundamental changes.
This forward-thinking approach has already proved valuable. When transitioning from previous generation of GenAI models to newer, more capable ones, ChatAIRI also reaps the benefits. Its operation gets faster and cheaper and responses more nuanced while maintaining its core reliability and traceability features. Designing this adaptability into your AI solution ensures that the investment continues to deliver value as AI technology evolves.
Conclusions
The ChatAIRI project for Santen Pharmaceutical illustrates four key principles for GenAI success:
- Solving Real Human and Business Challenges ChatAIRI supports regulatory work and frees up experts' time for strategic tasks. This focus on solving concrete problems, rather than adopting tech for its own sake, creates lasting value.
- Technology as Enabler, Not a Solution While ChatAIRI leverages latest GenAI capabilities, it's designed to enhance human expertise, not replace it. The solution augments regulatory experts' work through intelligent features and safeguards.
- The Human Element: Collaboration and Upskilling Success came through close collaboration between Brightly's team and Santen's experts, involving users in the design process and understanding their workflows.
- Embrace Iterative Design: The development process required constant refinement based on user insights and technical realities, demonstrating that successful AI projects need more adaptability than traditional software development.
The ChatAIRI project demonstrates that GenAI success lies in thoughtfully applying technology to solve real business problems while empowering human experts.
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