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Driving RIM Excellence and Innovation Through a Data-Centric Approach
Jul 23, 2025 | Paul Attridge
Jul 23, 2025 | Paul Attridge
To keep pace with evolving health authority (HA) standards, organizations are taking a data-centric approach with unified RIM systems to improve regulatory efficiency and agility. Industry leaders shared how they are increasing data quality, improving process governance, and enabling continuous publishing at the Veeva R&D and Quality Summit, Europe. For one global biopharma that has grown to over 15,000 users since going live with Veeva RIM in 2024, 72% of users are confident using the new system and 76% acknowledge the benefits of a unified solution.
Here are some key takeaways from discussions with global biopharmas:
Connecting RIM data across the enterprise to increase operational efficiency
Organizations are recognizing the value of a unified RIM platform to drive enhanced data quality and process excellence. A generics company implemented Veeva RIM while educating users on the importance of high-quality data and its business impact. “End-to-end data flow is very useful because we are responsible not only for the regulatory activities, but also to ensure other functions within the company get the right information,” said the company’s head of global regulatory strategy. Within just a couple years from implementation, the company ranked top tier in an industry performance analysis survey. “Veeva is not just a new software tool, you need to change your behavior toward data.”
One global biopharma implemented Active Dossier to consolidate data spanning multiple related entities to ensure data quality is maintained at every level. “Active Dossier consolidates data from across the whole RIM Vault, and this gives us transparency of our data that we have not had before,” said the biopharma’s regulatory program director. Improved data and document visibility helps the company efficiently perform change assessments, plan submissions, and support compliance for product batch releases.
Companies are focusing on long-term data management strategies that support cross-functional technology infrastructure and processes. For instance, some organizations have ongoing initiatives to build master data management (MDM) systems that seamlessly integrate product data with Veeva RIM for enterprise-wide data and process alignment.
Accelerating submissions with continuous publishing and quality data
With Veeva Submissions Publishing on a unified RIM platform, organizations can accelerate submissions to deliver medicines to patients faster and with fewer resources. One generics company used continuous publishing to manage an average of more than 100 daily submissions. Confidently and easily reusing data and documents throughout the entire submission process helps biopharma companies streamline operations. “Efficiency starts by building best-in-class processes which are supported by accurate and standardized data,” said the company’s vice president of regulatory operations.
Another generics organization implemented Veeva Submissions Publishing to manage a significantly higher volume of submissions. Within weeks of implementation, the organization submitted post-approval changes and four major biologic license applications (BLAs). When comparing the increase of submission volume from 2020 to 2024, the company saw a 40% increase in efficiency with continuous publishing while using fewer resources.
Driving adoption to strengthen data and process excellence
Every organization will have a different change management strategy when implementing a new RIM system. However, user adoption is key to any organization’s success. As one biotech’s head of global regulatory affairs digital and publishing points out, “implementation is not just about system deployment. It’s more about having our end users confident, ready, and capable to use the system to get the most from Veeva.” Extensive user support and training on the importance of data ownership and accountability are critical for data quality, especially for key activities such as data entry and data processing. “Data governance and data management go hand-in-hand to uphold data quality,” said Kim Brownrigg, Veeva’s regulatory practice lead, R&D Business Consulting.
After going live with Veeva RIM, one global biopharma launched development of a center of excellence to drive adoption and measure success. For continuous improvement, the company organized a process for addressing user feedback and pain points with actionable change. The company’s RIM product manager explained “we are here to improve the usability, and the look and feel for end users, to make sure they get the most benefit out of the system.”
To watch key regulatory sessions from this year’s Summit in Europe, go to Veeva Connect