Pilot to Production: Building the Business Case for Global Labeling

In today’s increasingly complex regulatory landscape, pharmaceutical companies face mounting pressure to streamline their global labeling operations. Before diving headfirst into a full-scale global labeling transformation, a targeted pilot engagement offers a strategic and risk-mitigated approach.

A well-designed pilot not only illuminates current-state gaps across document management, content structuring, and publishing outputs but also validates how new technologies, like component-based authoring and generative AI, can address those gaps. It provides stakeholders with critical insights into future-state workflows, ensuring the broader organization is prepared for a scalable, global rollout.

Diagnosing the Present: Identifying Inefficiencies and Gaps

One of the primary objectives of a pilot is to uncover and document process inefficiencies hidden in fragmented systems, inconsistent templates, and manual publishing workflows. By mapping current-state process flows and labeling use cases, teams can assess how structured content, reusable components, and standardized templates could reduce rework and accelerate timelines.

Test scripts executed during the pilot simulate real regulatory scenarios. These exercises provide practical insights into how structured publishing outputs—like FHIR, SPL, and Health Canada’s XML monograph format—can be supported and validated. The pilot acts as a pressure test for both the system and internal processes, helping stakeholders uncover and prioritize what matters most.

Introducing GenAI Authoring: From Static to Smart Drafts

Equally important, the pilot introduces teams to the benefits and boundaries of generative AI authoring in a controlled, measurable way. Trained on public regulatory data and fine-tuned with company-specific examples, AI models can parse unstructured source content and generate structured first drafts across multiple label types.

Rather than replacing authors, this process enhances them, allowing experts to focus on content review and risk management instead of formatting and copy-pasting. Through prompt engineering and scenario-based validation, the pilot ensures AI-generated content meets regulatory and quality expectations while remaining customizable to the organization’s voice and risk profile.

Engaging Stakeholders Across the Business

A successful pilot is not just a technical test; it’s a cross-functional alignment effort. Regulatory, labeling, IT, and quality stakeholders must all come together to evaluate structured authoring solutions, assess change management needs, and co-create the future-state model.

This collaborative approach helps define governance models, align around training requirements, and evaluate how the solution will support localization, component versioning, multi-language outputs, and audit readiness. It ensures the global solution is not just functional but also practical, scalable, and aligned to regulatory realities.

Case Study: From Pilot to Readiness with a Top-15 Pharma

One top-15 global pharmaceutical company recently partnered with Glemser to conduct a structured content and generative AI pilot using ComplianceAuthor AI®. The company faced mounting regulatory complexity and shrinking margins, while managing labeling through outdated systems, static templates, and email-driven workflows.

The pilot began with an in-depth process mapping and requirements gathering phase. Key use cases were selected to reflect real-world pressures, including multi-market label variations and first-draft generation for both USPIs and SmPCs. The pilot demonstrated:

• Component reuse across label types

• Automatic formatting for highlights and table of contents sections

• Generative AI transforming CCDS into componentized USPI and SmPC drafts simultaneously

• Configurable support for FHIR, SPL, and other structured formats

Built-in audit trails, versioning, and compliance controls gave the team confidence in the system’s regulatory robustness. More importantly, the pilot revealed significant improvements in speed, consistency, and content reuse—laying the foundation for a confident global rollout.

Quantifying the Impact: Business Value of a Pilot

Pilots aren’t about theory, they’re about evidence. They provide tangible metrics to justify broader investment:

• Reduced cycle times

• Fewer manual edits and version control issues

• Improved first-draft quality

• Faster onboarding for local labeling teams

In the case above, the pilot validated that structured content and AI could streamline operations, reduce regulatory risk, and improve agility. By engaging early with real content and real users, the business case was no longer hypothetical.

Preparing for What’s Next

As the industry evolves toward global standards like FHIR, IDMP, and XML-based ePI frameworks, regulatory and labeling teams must be ready to respond quickly. A pilot helps organizations stress-test not just the tools, but their own processes, roles, and readiness for change.

With AI and structured content accelerating the shift to scalable, compliant systems, piloting is increasingly effective. It’s the first step in making sure your organization can move with confidence from fragmented to future-ready.

By investing in a collaborative pilot today, pharma companies reduce risk, build internal alignment, and gain the momentum needed for a truly global labeling transformation.

Originally published at Glemser.com

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