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Pharma Tech Outlook | Sunday, July 19, 2020
Regulatory operations have transformed into a smarter function, from collating managing, and publishing terabytes of data in the printed paper form to utilizing state of the art systems for consolidating and publishing outputs in just a few clicks.
FREMONT, CA: Regulatory operations have substantially evolved in the past few decades. There are three essential contributors to this change. First is the evolution of regulatory requirements like eCTD, xEVMPD, and IDMP, harmonizing information management practices within the industry. The second factor is the increasing pressure to find more efficient operating models and smarter ways of working due to the rising lifecycle management burdens and shrinking budgets. The last element is the maturation of cloud-native and digital technologies that transforms the regulatory process and drive efficient operation. With the advent of end-to-end solutions like Veeva Vault RIM, pharma companies can unify organizational data and content, enter data only once, and make critical seamless cross-functional connections to quality, clinical, and safety.
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[vendor_logo_first]However, regulatory functions are still trying to realize the full benefits of multi-year, million-dollar transformations. Although smarter technologies like Veeva Vault RIM can aid in improving operations, it is still vital that regulatory operations groups utilize their functionalities in a specific way for their organizations. The most crucial success factor for any organization deploying this new cloud-native or digital solution is embracing the opportunity to standardize and ease business processes and operating models. Doing so, they can drastically improve the global user experience and achieve more significant business benefits.
Companies have to develop smarter and simpler operating models to realize system and process efficiencies. User acceptance and buy-in are vital elements for successful transformations, and involving the end-users throughout the transformation is vital. Companies have to think about smarter and more digital ways to engage with their user community, especially in change management and communications. This might seem like a lot of work upfront, but it substantially benefits in the long run.
The argument for embarking on extensive RIM transformation usually process efficiencies and productivity gains. Furthermore, organizations need to realize that merely replacing systems will not take away all pain points.
We’re seeing companies and software vendors moving to a process-centric view and end-to-end solutions, like Veeva Vault RIM, leading the way. The onus is on companies to quit looking at individual capabilities, data, or content and take a complete view of these technologies to understand how they can leverage them to manage the day-to-day processes. An innovative technology solution coupled with a well-defined process and good quality data can significantly reduce costs and improve efficiency by up to 30 percent.
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