ArisGlobal Viewpoint: How Digitization Changes the Role of Regulatory Affairs

Apr 24, 2017

ArisGlobal Viewpoint: How Digitization Changes the Role of Regulatory AffairsThis is the last in the ArisGlobal three-part blog series on Regulatory Affairs transformation. Digitization is sweeping the life sciences industry, disrupting traditional working practices and opening doors to better ways of collaborating, tracking and sharing documents and data, and gaining clear oversight into the product supply chain.

The digital supply chain, for example, makes it possible to keep track of which product is where across manufacturing, shipment, marketing, and distribution. As a result, companies can ensure counterfeit products aren’t being used and they can monitor volume to meet demand.

In terms of Systems of Engagement for regulatory affairs, digitization of the supply chain requires quick provision of expected approvals and potential delays so that information can be fed back into the supply chain to the point of patient access. That, in turn, allows every department with touch points in the supply chain to respond accordingly.

The Internet of Things (IoT) is also having a profound impact on both the supply chain and regulatory affairs, making it possible to track the flow of the authentic drug through the supply chain to the patient. For this to be possible, each product requires a unique ID, and the best time to assign those IDs is during the approval process, which affects the solutions that regulatory affairs use, as well as their standard operating procedures.

Social Connections

Social media also influences they regulatory affairs collaborates. In fact, the new breed of regulatory managers now use social media to collaborate in real time. And while that advance is welcome in many ways, it does create a headache in terms of auditing the contact between global regulatory affairs and the affiliate. The question, therefore, is how can companies enable their regulatory information management systems (RIMS) and other applications to talk with social media? And can their RIMS look into the social listening feeds of all the employees who are users of the system and manage their workflow?

One digital trend that’s just starting to be explored by the life sciences industry is the application of blockchain technology as a way of exchanging documents with outsourcing partners, affiliates, and other organizations. Blockchain technology would allow documents to be exchanged in a secure way. Such a change would have huge implications for regulatory affairs, transforming the way they develop, work with, and exchange documents.

As the Life Sciences Industry starts to address digitization, how it will impact RIMS in the future must be a primary consideration today in order to make the right kind of RIMS investments. Digitization is yet another driver for regulatory to consider on top of other strategic business drivers our ArisGlobal expert discussed in the other two blogs in this series, “How Regulatory Affairs Needs to Adapt to Transformation Change” and “Think Big: How Regulatory Affairs Needs to Adapt to Transformation Change.”

Join Pratyusha Pallavi, Product Manager, Regulatory at the eRegulatory Summit, April 25-27 in Madrid, where she’ll be presenting on the topic of Regulatory 2020: Technology-Fueled Business Transformation, and where ArisGlobal will be also exhibiting.

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