Taking the complexity out of regulatory governance in an era of digital transformation

The fast pace of technology innovation and digital transformation has added another layer of complexity for life sciences companies trying to manage their regulatory governance and compliance.

However, at the same time, business leaders need to embrace the digital transformation to create efficiency, drive competitive advantage, reduce costs and deliver business value beyond compliance.

How do life sciences companies manage these compliance challenges and derive value for the business? There are three distinct areas where the business typically faces challenges, but embedded in each of these are clear and progressive paths to transformation.

Strategy and architecture

As the amount of enterprise data and the speed at which it is gathered continues to increase, it has become imperative that companies consolidate their strategy for the storage, use, management and governance of their data.

Establishing an effective strategy and architecture for Regulatory Information Management (RIM) and introducing a rigorous and formal approach to enterprise data are the cornerstones of gaining a competitive advantage. In doing so, companies have better access to their enterprise data and can quickly gain the insights and intelligence needed to support business initiatives.

Properly architecting the enterprise is also important for future expansion — whether through mergers and acquisitions or by organic growth.

When considering their strategy and architecture, business and IT decision makers should pay attention to data management and enterprise regulatory architecture to ensure that knowledge can be shared across the business and analytics. They should carry out a best-practices assessment, a strategy and architecture “health check,” and return on investment assessments to ensure that their systems strategy aligns with the company’s business objectives.

Systems integration and deployment

The next critical step in regulatory governance is to “connect the dots” by bringing together diverse technology and business environments across the wide variety of regulatory software, hardware, platforms and technology.

Adopting systems integration is necessary for building an effective regulatory strategy. One of the big challenges life sciences companies have struggled with is being able to access unstructured data — that is, the information that exists in emails, PDFs and other unstructured sources. But this data often contains valuable insights that could provide competitive advantage. Systems integration helps companies unlock those sources of data.

In addition, systems integration makes it easier to seamlessly add new regulatory solutions or extend existing solutions, and therefore to take advantage of the digital transformation.

To prepare the organization, it’s important that project managers pay careful attention to migration, data governance, regulatory validation and product support. Working with an experienced partner ensures that regulatory systems comply with relevant standards and best practices, and that the organization gets maximum value from its regulatory products.

Program and project management

Given the scale, complexity and broader impact of regulatory programs, it’s important that there is strong leadership and detailed project management. As transformational projects are likely to affect many different functions and systems, it’s equally vital that projects are managed concurrently and collaboratively.

Having a strong program and project management team will make it much easier to ensure effective control and proper monitoring of the whole program. This team can oversee multiple integrated projects across the organization, and effectively achieve enterprise-wide change. A strong program-management office provides overarching control of the complex sets of technology projects required not only from a regulatory project perspective, but also needed to manage the overall business objectives. This includes strategic direction, operational management and effective governance — delivered in a way that reinforces company culture.

Well-planned program and project management provides the leadership needed to ensure that the multiple integrated projects making up a program deliver the desired outcome, on time and on budget.

Wendy Gilhooley is offering lead for DXC’s Life Sciences Regulatory Transformation Services (RTS).


  1. […] Taking the Complexity Out of Regulatory Governance in an Era of Digital Transformation […]

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