Accelerating compliant innovation in drug-device documentation
Pharmaceutical and medical device companies operate in one of the most tightly regulated landscapes in the world, where every product iteration demands exhaustive documentation and validation. Every new drug-device combination demands Design History File (DHF) documentation, to prove compliance with global medical regulations. Yet, creating DHFs is notoriously resource-intensive: it requires deep expertise, cross-functional collaboration and precision in aligning requirements with evolving regulatory frameworks.
Our client, a leading American multinational pharmaceutical company with a long legacy of healthcare innovation, faced mounting complexity in preparing DHFs for next-generation drug-device therapies. Manual processes, disparate repositories and shifting standards created bottlenecks that slowed submissions, increased risk and burdened engineering and regulatory teams.
HCLTech was chosen as the strategic partner to modernize DHF generation through GenAI capabilities, bringing automation, intelligence and consistency into a critical process, that underpins product approvals and patient safety.
The Challenge
Creating Design History Files (DHFs) for a diverse drug-device portfolio, proved to be a complex and resource-intensive task for the client. Knowledge was fragmented across legacy repositories, making it difficult to retrieve, validate or reuse requirements. Frequent staff turnover compounded the issue, leading to the loss of critical knowledge and inconsistencies in documentation quality. With processes heavily reliant on individual expertise, variability in requirement authoring often resulted in uneven outputs and costly rework.
At the same time, evolving medical regulations demanded constant updates, while the high combinatorial complexity of drug-device permutations multiplied documentation needs. Manual validation processes further slowed progress, as ensuring completeness, compliance and accuracy became a bottleneck. Without integrated quality controls, the client faced heightened regulatory risks, delayed time-to-market and increased resource burdens in managing a process that sits at the very heart of innovation and patient safety.
Our Solution
Our team of experts worked closely with the client to architect and deploy a GenAI-driven solution that streamlined DHF preparation and improved regulatory readiness. The phased program blended advanced AI capabilities with domain expertise, embedding intelligence and automation across the DHF lifecycle.
Key highlights
- Automated DHF preparation: Streamlined document creation by automating repetitive tasks and reducing human intervention.
- GenAI-powered NLP intelligence: Leveraged advanced natural language processing to identify relevant and similar requirements across historical repositories for faster reuse.
- Contextual requirement generation: Used AI to draft new, context-specific requirements aligned to drug-device combinations.
- Regulatory alignment and validation: Developed automated checks to validate requirements against evolving medical standards, ensuring compliance integrity.
- Requirements quality framework: Embedded evaluation mechanisms based on INCOSE standards and custom client guidelines to raise consistency and quality.
- AI-enabled review efficiency: Accelerated review cycles by highlighting gaps, redundancies and alignment issues early in the process.
The impact
HCLTech’s GenAI-led transformation enabled the client to achieve measurable improvements in speed, quality and compliance across its drug-device documentation lifecycle. By embedding AI into DHF generation, the solution reduced complexity, strengthened regulatory assurance and accelerated time-to-market for life-saving therapies.
Accelerated development at scale
- Achieved a 35% reduction in time and effort for DHF generation, streamlining end-to-end preparation.
- Enabled 45% faster review cycles, driving quicker regulatory submissions and product launch readiness.
Improved quality and reduced risk
- Delivered a 50% improvement in requirement quality through consistency, validation and adherence to standards.
- Reduced compliance risk with automated checks against evolving global medical regulations.
Enhanced resilience and knowledge retention
- Lowered dependency on individual expertise by institutionalizing knowledge into AI-driven processes.
- Strengthened continuity and reduced rework through systematic reuse of validated requirements.
HCLTech is extending GenAI capabilities beyond DHF automation to transform the wider life sciences value chain. From streamlining clinical trial protocols and regulatory submissions to embedding AI into quality management systems, we are driving greater consistency, traceability and speed. By automating labeling, compliance monitoring and standards alignment, while institutionalizing knowledge reuse for future therapies, we are building a future-ready compliance ecosystem.
This partnership empowers faster approvals, safeguards quality and accelerates the delivery of transformative healthcare solutions worldwide.
