Picking up the Pace: How RIM Agility Enables Proactive Compliance
Around the world, the pace of regulatory change continues to increase in life sciences, as regulators change requirements and add new ones. Sweeping directives such as ISO’s IDMP (Identification of Medicinal Products) and ICH’s EU CTR (Clinical Trial Regulation) are changing the way that biopharmas approach regulatory data and document management. The move from narrative to data-based regulatory submissions, now in its earliest phases in CMC submissions1, promises to bring more change in the future and require a greater focus on regulatory data quality and transparency.
In this dynamic environment, companies need to share data more effectively – both internally, across functions, and externally with regulators and contract partners. At one leading enterprise biopharma company, regulatory leaders decided to move to cloud-based regulatory information management (RIM) systems in 2016, when IDMP regulations began to take shape in the EU and threatened to impede its ability to manage a growing product pipeline.
The company had found that fragmented data and documentation, as well as overreliance on highly customized software, had slowed its ability to respond to global regulatory and business changes. For variation management in manufacturing, the company struggled to assemble critical data that was dispersed in different silos, e.g., health authority interactions, product registration data, and submission records.
Managers saw the need to combine data and content management, and to strengthen connections between regulatory, clinical, and manufacturing functions. They also realized that a centralized approach to change management would be crucial to ensure user adoption.
The team took a long-term, systematic approach to improve RIM processes, data, and documentation. Now in its sixth year, the effort has enabled teams to make decisions based on real-time or close to real-time data and resulted in dramatic efficiency and other improvements.
Separating content into clinical, quality, and submissions categories
First, the team studied processes and workflows, and areas to improve. Members agreed that a new registration management system and new submission publishing software were needed, as well as a new document management system.
The company had always managed both clinical and regulatory content in one place, but that approach resulted in a large and complex system that was difficult to update. The team decided to separate clinical, quality, and submission-related content, establishing centralized data and document management for each of the three functions in parallel.
Next, it tackled the company’s highly customized registration management processes, which were expensive to maintain and run. The team selected Veeva Vault RIM Suite to centralize all regulatory data and documentation and connect it across clinical and quality functions on a common Vault platform.
Removing overhead infrastructure costs allowed the team to focus on more value-added tasks. Automating processes also proved to be a key to boosting efficiency in the exchange of information between functional areas.
The company had set a two-year deadline for completing the work to get ready for IDMP. Once the new registration approach went live, it shifted focus to simplifying the publishing process with Vault Submissions Publishing, which launched six months later.
More frequent improvements and updates
Overall, the new system gives the company greater agility. With its previous software, the regulatory team was limited to making one change to the system every year. With Vault RIM, they can now make from three to six updates a year (three for Vault and up to three for company practices), enabling them to adapt much faster to external changes and to move toward proactive compliance.
The new applications have also made accurate data available in close to real time. Teams can now benefit from increased data transparency, so that whenever delays occur in particular processes or workflows, or at specific sites, they can quickly diagnose the issue and introduce a solution. This sets a foundation for continuous improvement.
By enforcing validation checks and rules, the company improved data governance and made system users more accountable. The company has also created new roles – for example, “release train engineers” who focus on getting the most out of the applications throughout their life cycles.
The company’s reimagined approach to RIM has not only made compliance more systematic today but promises to ease the adjustment to whatever changes the future may bring. The heightened focus on data transparency and quality can only help, if and when the industry moves from document- to data-based regulatory submissions.
Greater agility helps an innovator manage fast growth
Cloud-based RIM has also improved efficiency at a growing mid-sized biopharma company. Company leaders realized that a change was needed once its pipeline of new therapies began to grow rapidly around the world and into new product areas. Its regulatory team struggled to keep up with new product registration filings.
Its previous RIM software required a significant amount of human intervention. Manual workarounds and the knowledge of experienced staffers ensured that operations ran smoothly, but vulnerabilities lurked beneath the surface. For example, the company had no central repository for keeping track of the deadlines for filing documents with different global regulators. Instead, this information was maintained in people’s heads and on a few paper spreadsheets.
Initially, regulatory managers had planned to implement a new document management system. However, once they took a deeper look at existing processes and performance gaps, they saw that more fundamental change was needed. A group of submission process champions was established to evaluate alternatives, and they decided to implement Veeva Vault RIM.
Efforts began in early 2020 with submissions and the submission archive, then moved to health authority interaction and correspondence, wrapping up in late 2021 with registrations and integration between the different regulatory systems.
So far, the Veeva Vault RIM system has saved the company a considerable amount of IT maintenance, operation, and validation costs, but has also enabled much greater efficiencies. Features such as collaborative authoring have been a major improvement over last-generation technology, and the system offers much more granularity around version control and workflow.
The company is now connecting its RIM system with clinical data and documentation in Vault CDMS and Vault Quality, using the Veeva Development Cloud to improve cross-functional collaboration.
To learn more about how Vault RIM helps organizations streamline operations, read this customer story on Mundipharma.