Rapidly Deploying a Global Quality Solution at Shire

This video details Shire’s experience in the rapid, global deployment of Veeva Vault QualityDocs, a specialized document management system (DMS), following the company’s divestiture from its parent organization. The core challenge was the immediate need to establish a compliant, standalone quality solution capable of managing approximately 1.2 million legacy documents and supporting 20,000 users across the world. Anil R. Bharwani, Director of IT, Quality and Environmental, Health, and Safety at Shire, explains that their previous system, a Product Lifecycle Management (PLM) solution, was fundamentally inadequate for the specific requirements of pure document management, necessitating a comprehensive search for a specialized replacement.

The vendor selection process was rigorous, starting with 18 potential companies before narrowing down to a few finalists. Veeva Vault QualityDocs was evaluated against other top industry vendors and ultimately chosen due to its superior user experience and functionality. Key benefits cited by Shire included the system’s intuitiveness, ease of use (requiring very little training), highly effective search capabilities, and robust collaboration features, all of which significantly surpassed the capabilities of their previously used internal systems.

The project was executed under an extremely tight deadline. Funding was secured in January, and Phase One of the global deployment went live in July, making the new system immediately accessible to all 20,000 global users within six months. The immediate success was quantifiable, with post-go-live statistics showing phenomenal activity, including over 400,000 sign-ins and 200,000 document changes recorded shortly after launch. This rapid adoption validated the system's user-centric design and the effectiveness of the deployment strategy. A critical piece of actionable advice offered by the Shire team, based on their experience migrating massive amounts of data, is the absolute necessity of dedicating time to map and clean legacy data structures before moving them into Veeva Vault. This proactive data hygiene step is crucial for minimizing backend issues and ensuring a smooth transition for end-users.

Key Takeaways: • Veeva Vault as a Critical Divestiture Solution: The project was driven by the need for a standalone, compliant IT infrastructure following a corporate separation. Veeva Vault QualityDocs proved capable of handling the massive scale (1.2 million documents, 20,000 users) and the aggressive timeline required for rapid operational independence in a regulated environment. • Superiority of Specialized DMS: Shire’s evaluation process, which included 18 initial vendors, confirmed that specialized platforms like Veeva QualityDocs offer significant advantages over generalized enterprise systems (like their previous PLM system) when it comes to core document management, collaboration, and search functionality in a GxP context. • Aggressive Deployment Benchmarks: The successful transition from project funding approval in January to global Phase One go-live in July sets a critical benchmark for rapid enterprise software deployment within the pharmaceutical sector, demonstrating that large-scale, compliant system implementations can be achieved within six months. • User Experience Drives Adoption: The primary benefits highlighted—easy to use, intuitive, and requiring very little training—underscore that user-centric design is paramount for achieving high user adoption rates, especially when rolling out a new regulated system to tens of thousands of global users. • Data Preparation is the Single Most Important Step: The most crucial recommendation from the implementation team is to invest significant effort in mapping and cleaning legacy data before migration. Failure to clean source data will lead to substantial issues on the backend and negatively impact user satisfaction once the data resides in Veeva Vault. • Validation Through Usage Metrics: Immediate and high-volume usage statistics, such as over 400,000 sign-ins and 200,000 document changes shortly after launch, serve as concrete evidence of successful system adoption and immediate operational value realization. • Addressing PLM Limitations: The speaker explicitly noted that while their previous PLM system performed certain tasks well, it struggled with the specific demands of pure document management. This insight is valuable for consultants advising clients to move specialized functions, like Quality Docs, onto dedicated platforms. • Focus on Collaboration and Search: Beyond basic storage, the enhanced collaboration features and intuitive search capabilities of Veeva QualityDocs were key differentiators that improved operational efficiency compared to Shire's previous system.

Tools/Resources Mentioned:

• Veeva Vault QualityDocs: The implemented document management system (DMS) tailored for quality and regulatory documents.
• PLM (Product Lifecycle Management) System: The legacy system previously used for document management, which was deemed inadequate for the scale and specific needs of a global quality solution.

Key Concepts:

• Legacy Data Mapping: The essential process of defining the structure, metadata, and relationships of data from the old system to ensure accurate and compliant transfer into the new Veeva Vault environment.
• Global Quality Solution: A unified, standardized system for managing quality documentation and processes across all worldwide sites, crucial for maintaining consistent regulatory compliance (implied GxP adherence).

Examples/Case Studies:

• Shire Implementation: A case study demonstrating rapid, large-scale migration and deployment, involving 1.2 million documents and 20,000 users globally, executed within a six-month window.