How Regulatory Transformation Drives Transparency and Data Access to the Whole Business

There’s a growing realization across life sciences companies that the regulatory function — how it is managed from an infrastructure point of view, how it is governed, and how the data within it is managed and tracked — needs to be consolidated.

Increasingly, companies are looking to consolidate their distributed regulatory processes into a centralized, managed business unit, or into a loosely federated organization that considers the nuances and complexities presented by local requirements when managing regulatory compliance.

An important corollary to the regulatory consolidation taking place from a vertical point of view — leading to greater efficiency — is the evolving horizontal effect as that data collected in the regulatory space becomes more transparent and visible to other business towers across the company. This is important because it enables these towers or pillars — R&D, clinical, commercial, supply chain, manufacturing and marketing — to leverage this valuable data.

From data to insights

From a data point of view, three fundamental areas of change are driving the regulatory transformation and opening new pathways for business insights.

The first is newly discovered data, which is a by-product of new regulations, such as serialization regulations, which are creating a depth of inventory information that previously did not exist, thereby opening new insights into the supply chain.

The second is data that is uncovered due to data-discovery activities resulting from requirements such as Identification of Medicinal Products (IDMP), which brings to the forefront both structured and unstructured data needed to fulfill compliance requirements. The ability to leverage this data — particularly unstructured data, which typically had been hard to tap into — provides information to the broader organization that might be used for R&D, commercialization or elsewhere.

The third stems from the realignment of data as companies move to a consolidated approach to their regulatory processes. During this move, the data is cleaned, transformed, restructured and made available — through master data management — to the whole business.

At DXC Technology, we believe that the regulatory transformation combines several key elements, including infrastructure — for example, moving into a cloud environment to leverage best practices, business efficiencies and cost cutting; project management and governance, bringing together tools and techniques to address organization and transparency issues; and regulatory tracking in response to the need to know where the product is and how it is being used.

As companies move steadily away from scattered implementations of their regulatory processes and toward a center of excellence approach, they can better manage and empower different areas of the business, such as inventory control, position in the marketplace, brand protection and beyond.

Learn more about what DXC Technology is doing to enable companies to evolve from their current state of regulatory compliance support and strategy to a new business model whose underpinnings are primarily the digitization of the workflow.

Visit us at DIA 2017.


Rick Ruiz is a partner with DXC’s Life Sciences group.

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