A fundamental shift is taking place in the way companies are approaching regulatory compliance. A lack of structured data is proving to be a substantial liability—as ill-prepared companies are learning the hard way—which is leading more organizations to move away from conventional document-centric methodologies and toward a data-centered model of compliance.

This trend is particularly pronounced in the life sciences where companies have traditionally been mired in mountains of documentation because they tend to base their analyses and reporting activities on historical data. But as Big Data continues to get bigger and harder to manage, more companies are finding their compliance information trapped in documents that are siloed in disparate systems or inaccessible when needed most.

To offset the dilemma of disconnected documents, companies are adopting a new data-centered compliance mindset. Realizing that maintaining compliance by focusing primarily on documentation is insufficient, forward-thinking organizations are now directing their efforts toward improving access to actionable, accurate data and enhancing their ability to analyze that data. As the Deloitte Centre for Health Solutions noted of the new trend, “Applying advanced data analytics techniques could enable companies to identify and quantify—proactively—new and/or emerging risks.”¹

The new data-centric approach to compliance, while necessary, does come at a cost, however. Not only does an intensified focus on data compel a company to rethink and redesign its overall processes, it also requires a modernization of its infrastructure, software and processes for quality management. But the cost of investing in modernization is far outweighed by the cost of noncompliance that will inevitably be caused by unstructured quality data.

Robust digital solutions are leading the charge in the shift to data-driven compliance by enabling life sciences companies to take control of their quality data and providing it with a reliable structure. Modern quality management systems (QMS) are specifically designed to digitally connect data across the enterprise and drastically simplify any restructuring of quality activities that a company needs to undertake as it strives to make its compliance processes more data driven.

Connecting the Life Cycle With Future-Focused Platforms 

The current focus on data is bringing software platforms to the fore. Platforms are playing an increasingly larger role in compliance—especially in the life sciences—because they provide greater visibility into and control over data. Rather than piecing together disparate applications to coordinate multiple processes and data streams, a platform offers the reassurance of native connectivity and unifies all applications and processes within a common architecture and programming code base.

Running a variety of applications within a natively integrated operating system allows a company to take a product life cycle approach to compliance and achieve greater governance over its quality management processes. By design, platforms enable multiple interrelated processes to operate and synchronize within the same digitized framework, which is the primary reason platforms are proving to be the most effective mechanism for mapping data and process connections across product life cycles.

Platforms also continue to facilitate innovation and enable organizations to take the concept of “creating a culture of quality” to the next level by tightly correlating data and processes. They’re the ideal means of establishing compliance as a speed-to-market accelerator by enabling companies to achieve predictive insights and real-time quality intelligence.

Perhaps more importantly for companies that are poising themselves for growth, platforms facilitate adaptability and expansion when the need to evolve or pivot becomes warranted. Much like Apple’s iTunes platform transformed to become something far greater than a technology for purchasing and playing music and Amazon’s platform enabled it to become much more than an online bookstore, a robust platform for connecting business processes can provide a foundation for appreciable growth. As business processes change or new processes need to be added, platforms provide the consistency of a baseline technical framework that can be expanded upon and leveraged to spur innovation.

The Future of Compliance Software Platforms

As technology continues to transform what is considered to be the modern approach to compliance, those companies that were formerly perceived as being on the cutting edge for shifting from a reactive to a proactive posture are becoming commonplace. The inevitable next step in effective and comprehensive compliance management is the ability to move from a proactive state of readiness toward truly predictive competencies. The digital revolution is taking compliance management to the next level as QMS providers race to develop data-driven software offerings that feature predictive solutions that provide meaningful quality and compliance intelligence.

Gartner Inc.’s latest research outlines several key QMS platform capabilities that will be highly sought after by the industry leaders attempting to establish a pragmatic and data-centered approach to compliance. They include: 

• Functionality that ensures and enforces compliance.
• A user interface/user experience (UI/UX) that supports rather than hinders user adoption.
• The ability to promote transparency across the enterprise.
• Licensing and hosting options.
• Capabilities that are favorable toward being inclusive of new technologies without compromising core quality management functionalities.²

Looking down the road, the pioneering companies seeking to differentiate themselves and get products to market ahead of competitors will demand software platforms that can provide, at minimum, proficiencies such as: 

Enhanced access to data: The availability, structure and accessibility of data are becoming increasingly more important. In fact, over half (54%) of quality leaders surveyed by the CEB Quality Leadership Council indicated that attainability and usefulness are their top priorities in using data to improve quality. Critical decision-making is streamlined when the people who need timely quality and compliance data can access it quickly.

High-value uses for innovative tech: Finding a way to convert compliance and product quality data into real-time intelligence and predictive insights was once just a fantasy. Thanks to the relentless advancement of technology, it is the new reality. No-longer-nascent technologies like natural language processing, machine learning, and artificial intelligence are now gaining maturity and expanding companies’ options for leveraging their data. Solution providers are continually developing new uses for programs that extract text, contextualize unstructured documents, and other applications that continue to open new avenues for streamlining quality and compliance processes.

Scalability and adaptability: In the ever-evolving world of regulatory compliance, there is no such thing as a set-it-and-forget-it system. Regulatory and business priorities are always changing, and companies need flexible solutions that enable them to keep up with changing circumstances. This concept of compliance solutions needing to be ready for both the present and the future was summarized in a recent Deloitte Centre for Health Solutions research report that stated: “Compliance systems have to be effective, efficient and future-proofed to support existing compliance requirements and mitigate new and emerging compliance risks.”⁴ 

Conclusion

As the quality world shifts to a data-centric model, no company can afford to put compliance and quality processes at risk by relying on outdated methods or unproven software. The future of quality lies in data intelligence, and reliable software platforms can help companies be ready for a future where data is king.

Implementing a platform with a proven track record can provide the efficiency, connectivity and ease of use that a company needs to conduct and manage quality and compliance operations through a single integrated solution. What’s more, a robust, future-ready platform can empower companies with the adaptability they will need to cope with unrelenting technological advancements and an evolving regulatory landscape.

“The challenge of compliance in life sciences,” Deloitte Centre for Health Solutions, 2015.

“Market Guide for Quality Management System Software,” Gartner, Inc. 9 Sept. 2019. Sam New, Analyst.

“Advance Quality Performance Through Data-Driven Insight,” CEB Quality Leadership Council, 2017.

“The challenge of compliance in life sciences,” Deloitte Centre for Health Solutions, 2015.