As the pharmaceutical industry adapts to a new world with a new set of challenges, it is critical to keep global teams aligned. There’s more emphasis on speed, efficiency and collaboration than ever and the need for it to be delivered in an end-to-end unified platform is vital. In the regulatory domain, there has been a move towards a unifying system in response to the needs of the market. Let’s explore the benefits of a unified system and examine the challenges involved.
Why Choose a Unified System?
Currently in regulatory, a lot of smaller point systems are being used. If companies make the shift to a unified system that supports a variety of functions, it will drastically improve the overall user experience and data quality. By reducing the need to use multiple systems, it eliminates the requirement for extensive training as well. This saves time and money while increasing productivity. Additionally, data models that are used in different systems are not always in sync.
This leads to a disconnect between various models and it can take a considerable amount of time for global teams to align their data and gain accurate insights from each other. By making the shift to a unified, end-to-end system, companies will save time and empower teams to make smarter decisions, faster. Just imagine entering product data once that can be used over and over. A unified system streamlines the entire regulatory process.
What are the Main Challenges That Exist?
Data alignment and standards continue to be one of the biggest challenges that exist when considering the push toward a unified system in regulatory. What one company or department may see as an identifiable piece of data, another company or department may view as something else, which makes alignment of data difficult. The importance of data standardization is more critical than ever, especially following the COVID-19 challenges and the recent BREXIT updates.
In a session on “The Unified Future of Regulatory Platforms” at ArisGlobal’s virtual summit, Breakthrough, Hans van Leeuwen, Head of Regulatory Operations, Europe, at Astellas, amplified this point of view.
“I think data alignment is key for any of these unification approaches. If you look at a product definition at any one of these pharmaceutical companies, it’s slightly different.” If we don’t give the holistic overview of what the end product will be, it will continue to cause some discrepancies at some point,” he added.
The evolution of new standards such as IDMP (Identification of Medicinal Products), could be seen as a way to overcome these data related challenges. While data unification is a challenge, the faster it is adopted, the more streamlined and efficient the life sciences industry will be. Fortunately, our RIMS solution includes full IDMP compliance where standards have been released requiring an internationally accepted framework for consistently documenting, coding, and exchanging data among global regulators, manufacturers, suppliers, and distributors.
How Will Unification Affect Regulatory in the Future?
Having a unified system will help collaboration and communication between cross functional teams. Many data alignment challenges currently exist in the regulatory sector. This is one of the main reasons why companies are looking forward to a bright future of unification.
“It’s not just about putting the processes in place but making them more efficient – making sure the technology that’s currently in place helps you with making the processes more efficient” said Wim Cypers, Senior Vice President of Strategy & Innovation at ArisGlobal. “At the end of the day, technology is only as good as the data you get.”
The perfect unified system does not currently exist. Companies are increasingly making the shift to add functionality to their current platforms. Smaller organizations are starting with content efforts like our EasyDocs solution, and others are adding IDMP alongside their existing RIMS solutions. There is no predetermined path and companies are addressing their needs at varying stages of their Regulatory maturity cycle.
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