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Blog: Embracing the Cloud: A Transformative Journey in Regulatory Operations

In the ever-evolving world of pharmaceuticals, a leading company has embarked on a transformative journey by moving its regulatory operations to the cloud. This shift from traditional on-premise systems to a cloud platform has revolutionized regulatory data management. This blog explores the details of this significant transition, highlighting the process, challenges, victories, and its impact on data governance and data sharing.

The Road to Cloud Adoption

The journey began twenty-five years ago with a vision to enhance the efficiency and accuracy of tracking submissions and approvals. Initially relying on spreadsheets and regional databases, the need for a centralized, scalable solution became evident. Over the years, the company evolved its systems, integrating more affiliates and adapting to new regulatory standards such as the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and Identification of Medicinal Products (IDMP).

The pivotal moment came in 2019 with the decision to fully embrace the cloud. This move was driven by the need to meet stringent regulatory demands. Since then, the cloud-based regulatory database has become a cornerstone system, supporting not only regulatory activities but also broader R&D initiatives.

Triumphs Through Teamwork

Transitioning to the cloud presented several challenges, with extensive manual data entry being a primary hurdle. Recognizing the inefficiency of manually transcribing digitally generated data, the company has been exploring automated data entry solutions to eliminate redundant processes.

From an IT perspective, the move to the cloud brought numerous advantages. Regular updates have made the improvement process more predictable and reliable. Single sign-on options have enhanced the user experience, and consolidating smaller systems into larger platforms has reduced maintenance costs. The cloud has also facilitated cost-sharing in technology development, allowing the company to benefit from industry-standard practices and innovations.

Data Governance and Stewardship

A significant transformation has been in data governance. The company established a comprehensive data governance framework within its Regulatory Affairs (RA) department. This framework is supported by a dedicated data stewardship team responsible for ensuring data accuracy, consistency, and compliance. By shifting data ownership to individuals responsible for generating the data, the company has enhanced accountability and streamlined data entry processes.

The data stewardship role has evolved from a support function to a strategic role within regulatory teams. Data stewards now play a crucial part in regulatory strategy, contributing to a deeper understanding of data points and their significance across the product development lifecycle. This shift has improved data quality and fostered a culture of data-driven decision-making.

Enhanced Collaboration and Community Building

The cloud transition has also fostered better collaboration both within the company and with external partners. The standardized platform has facilitated smoother interactions with other systems and databases, enhancing data-sharing capabilities. The shared user experience has strengthened the sense of community among regulatory professionals, promoting knowledge exchange and best practice implementation.

Journey in the Cloud Continues 

Looking ahead, the focus remains on leveraging this technology to drive operational excellence and innovation. The goal is to integrate more systems into the cloud framework, further enhancing capabilities in data management and regulatory compliance. Achieving first-time-right data accuracy, reducing the need for quality control loops, and ensuring timely and precise regulatory submissions are top priorities.

In conclusion, this move to the cloud represents a significant milestone in regulatory operations. The transition has improved efficiency and data quality and positioned the company at the forefront of regulatory innovation. By embracing the cloud, the company is setting new standards in data governance and data sharing, paving the way for a future where regulatory operations are more agile, collaborative, and data driven.

Join the Conversation! If you are on a similar journey or considering a move to the cloud, we’d love to hear your thoughts and experiences. Share your insights and questions in the comments below. Let’s drive innovation together in regulatory operations!

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