Transforming regulatory data management
Research & Development
Regulatory compliance is a top priority in the pharmaceutical industry. Managing accurate, accessible, and secure data presents a significant challenge, particularly when companies rely on outdated legacy systems. At BASE life science, we recently partnered with a leading pharmaceutical company to modernize their regulatory data management by successfully migrating to Veeva Vault, utilizing our proprietary BASE migration framework.
The challenge
Our client, a global pharmaceutical leader, was struggling with an outdated Regulatory Information Management (RIM) legacy system that was cumbersome and posed serious risks to data integrity and compliance. Recognizing the need for a robust, scalable, cloud-based solution, Veeva Vault emerged as the optimal choice – offering a comprehensive suite of applications designed specifically for the life sciences industry, streamlining global regulatory processes on a single platform. Our task was to extract, transform, and load regulatory data from the legacy system to Veeva Vault with minimal business disruption while maintaining regulatory compliance.
The solution
At the core of this transformation was the BASE Migration Framework, our proprietary software designed to handle complex data migrations with precision and efficiency.
Key steps in the migration process
Analysis and planning
We began with a thorough assessment of the existing legacy system, identifying critical data, potential risks, and compliance requirements. A comprehensive data profiling exercise provided a complete map of the source data, highlighting quality issues and identifying areas needing cleanup and enrichment. This groundwork enabled us to craft a detailed migration plan, meticulously addressing potential challenges and ensuring compliance with regulatory requirements.
Collaboration and best practices
We worked closely with the client’s business teams, providing valuable insights, and advising on best practices for data migration, based on our deep understanding of the regulatory data model in scope. This collaboration ensured alignment with the client’s operational needs and regulatory requirements.
AI-based metadata extraction
To enhance efficiency, we utilized advanced AI-based tools, specifically state-of-the-art Large Language Models (LLMs), to automate the extraction of critical metadata from documents. This significantly reduced the need for manual enrichment, a process often prone to errors and time-consuming. The enriched data was then rigorously tested by Subject Matter Experts (SMEs) and business representatives, achieving a precision rate of over 98%.
Migration execution
Using the BASE Migration Framework, installed on a cloud server that connected directly to both the source and target systems, we implemented precise mapping rules, ensuring data accuracy and compliance. Iterative testing in a sandbox environment allowed us to identify and resolve issues early in the process. By following agile principles, we maintained flexibility and adaptability, ensuring a smooth migration while enhancing overall efficiency and reliability.
Validation and testing
To validate the data migration according to Good Automated Manufacturing Practice (GAMP) requirements, we utilized our BASE Validation Framework. This comprehensive framework ensures a thorough and systematic approach to four key aspects: business, application, system, and end-user.
A standout feature of the BASE Validation Framework is its inclusion of automatically generated migration reports streamlining the validation process, reducing reliance on manual sampling and enhancing efficiency, data integrity, and compliance.
Hypercare
Following the migration, we implemented a hypercare phase, providing intensive support and monitoring. This ensured any post-migration issues were swiftly addressed, allowing the client’s team to fully leverage the new system’s capabilities.
The results
The migration to Veeva Vault was a resounding success. Our client now benefits from a modern, cloud-based regulatory data management system that offers enhanced security, scalability, and compliance. Key outcomes included:
- Speed-to-Market: Improved data quality and streamlined processes accelerating regulatory submissions and shortening time-to-market for new products.
- Enhanced compliance: Robust compliance features enabling the client to meet stringent regulatory requirements with ease.
- Global alignment: A unified platform facilitating coordination and consistency across global teams.
- Improved connectivity: An integrated system provided a single source of truth, enhancing visibility and connectivity across the organization.
The BASE Migration Framework
The BASE Migration Framework is a robust software solution designed to address the complexities and compliance requirements of GxP migrations. Developed by our top specialists and proven in 130+ migration projects, this framework ensures fast and reliable migrations while maintaining regulatory compliance.
Pre-qualified and easy to deploy in both cloud-based and on-premise infrastructures, our framework manages the end-to-end data flow seamlessly. With modules dedicated to source data extraction, analysis, cleanup, enrichment, transformation, and load to the target system, every aspect of the migration process is meticulously handled. Built-in audit logging and automated report generation provide full traceability and accountability, enhancing efficiency and transparency.
Read more about our Data MigrationsConclusion
This project exemplifies how strategic data migration, powered by innovative tools like the BASE Migration Framework, can create significant value for pharmaceutical companies. By transitioning to Veeva Vault, our client not only modernized their regulatory data management but also positioned themselves for future success in an increasingly complex regulatory landscape.
Want to know more?
If you’re interested in how we can support you, reach out to our experts today. We are happy to guide you on your journey.
