Powering high-integrity Application Lifecycle Management for Biopharma R&D
In the biopharmaceutical sector, accelerating product development must go hand in hand with uncompromising regulatory compliance. Evolving mandates and digital transformation have intensified the need for audit-ready, traceable and high-quality documentation across the R&D lifecycle.
Our client, a global biopharmaceutical leader with a portfolio spanning immunology, oncology, neuroscience, cardiopulmonary and specialty ophthalmology, partnered with HCLTech to modernize engineering, documentation and compliance workflows. Working closely with R&D IT and Quality teams, we set out to enhance efficiency and strengthen regulatory alignment.
To address inefficiencies in requirements authoring, validation and review, the client engaged us for a full-scale, end-to-end transformation of their Application Lifecycle Management (ALM) ecosystem. Using our GenAI-powered solution, we embedded AI-driven quality checks, guided authoring and standards-based automation into their Polarion ALM. This delivered higher requirements quality, reduced manual effort, accelerated reviews and ensured end-to-end traceability, enabling faster, compliant innovation.
The challenge
The client’s requirements authoring and review processes were time-consuming, manual and highly variable across teams, resulting in inefficiencies, delays and downstream quality issues. Although the baseline quality of requirements was often acceptable, the lack of automation and standardized guidance led to inconsistencies, rework and increased defect rates during later stages of development.
Requirement authors operated without real-time assistance, making it difficult to consistently apply Good Documentation Practice (GDP). Manual validation processes were labor-intensive and error-prone, placing additional strain on already extended review cycles. Moreover, the absence of a centralized, program-level quality dashboard meant leaders lacked visibility into recurring issues, trends and improvement opportunities, limiting their ability to track performance, enforce standards and drive targeted coaching at scale.
These challenges collectively slowed the client’s ability to deliver timely, compliant and high-quality outputs within their regulated product development and change-control environments.
Our solution
Our client collaborated with us to enhance requirements quality, automate INCOSE-aligned checks, embed GDP and deliver role-based dashboards, reducing authoring and validation effort while maintaining compliance and streamlining review cycles.
Phased enablement model with GenAI at the core:
- Set-up and governance: We established cross-functional engineering and quality squads within the client’s Polarion ALM environment, defining governance frameworks — rules, acceptance criteria, reporting cadences and change-control protocols — for scalability and audit readiness.
- Knowledge transfer and enablement: Targeted bootcamps trained authors, reviewers and program leads. As adoption grew, HCLTech assumed responsibility for quality analysis and reporting, embedding strong change management from the outset.
- GenAI quality engine: Our GenAI-powered engine automated requirement validation, providing context-aware suggestions to improve clarity, scope and testability. It operationalized 13 parameters and 41 rules aligned to INCOSE and client-specific standards.
- GDP validation: Embedded GDP checks delivered in-line authoring guidance, reducing rework, improving first-time-right rates and ensuring regulatory compliance.
- Quality monitoring and insights: Role-based dashboards offered real-time, drill-down quality views, enabling leaders to track trends, guide teams and proactively address issues.
Embedding GDP and standards-based validation strengthens data integrity, documentation rigor and audit readiness, critical for accelerating compliant biopharma product delivery.
The impact
Our solution reduced manual effort, strengthened compliance confidence and positioned global R&D and IT to scale quality-first practices.
Accelerated requirements delivery
- 50% reduction in time and effort for requirements analysis
- 60% faster updates to existing requirements
- Faster content creation with fewer hand-offs and less rework
Improved requirements quality
- 70% improvement aligned to INCOSE and client-specific standards
- Higher first-pass approvals; reduced downstream defect leakage
- Clearer, audit-ready artifacts supporting regulatory submissions
Faster, more predictable review cycles
- Streamlined validation workflows across programs
- Consolidated dashboards and in-line GDP checks improved governance
- Stronger traceability, lowering compliance risk
Future-ready evolution
- Expanding rulesets and guidance to test cases, risk files and other lifecycle artifacts
- Deepening alignment with INCOSE and regulatory frameworks
- Further cycle-time reductions via deeper automation and tighter linkage to verification and risk management
As a trusted transformation partner, HCLTech enables sustainable innovation and compliance confidence, accelerating safe, high-quality product delivery at scale.
Verwandte Fallstudien
100% regulatory compliance for global contract research organization
Our client faced operational inefficiencies and compliance issues in clinical trials. HCLTech provided an automated platform to enhance visibility, streamline processes, and ensure compliance
