A Time of Change: Drivers of a Life Sciences Evolution

A Time of Change: Drivers of a Life Sciences Evolution

While we have certainly spent a fair amount of time in various blog posts discussing the limitations of traditional document-based validation, today I would like to spend some time discussing some of the drivers of change – both on the business and the technology side –  that documents do not effectively support. Without adapting to these drivers and answering the call for change accordingly, legacy documents and documentation practices will continue to hinder the life sciences industry. Further, they will continue to largely overshadow the ultimate goal, which is quality software, systems, and product. 

While many organizations continue to work within the challenges and the limitations of legacy validation, some forward-thinking teams have already gotten well underway to implement modernization strategies around their CSV programs - and to great benefit. Ah, but I already get ahead of myself!

Before we get too deep into the what, how, and benefits of shifting to a more modern approach to CSV (or the incorporation of a CSA program), let’s spend some time recognizing and understanding some of the business and technology drivers that are prompting teams to move away from documents (whether they be paper or electronic). Why is there an increasing need to leverage a more streamlined approach to software compliance practices? What changes in recent years have really begun to highlight the limitations of traditional validation methodologies?

  • Globalization: As companies grow and expand beyond national borders, they need to adapt their validation procedures to the requirements not just of the FDA or other local governing bodies, but to a variety of different regulatory agencies. In addition, validation teams are now geographically dispersed making communication and collaboration critical elements to providing a consistent, defendable validation deliverable.

  • Shift to Remote Workforce: While companies were generally slow to adopt the telecommuting workforce model, the advent of COVID-19 accelerated that trend -- dramatically. Companies that were accustomed to in-person collaboration, reviews, and approvals struggled to adjust and compensate for that change. In stark contrast, companies that already had digital validation tools and processes in place experienced little to no interruption to their business. And while COVID-19 will eventually be a thing of the past, many organizations will retain the remote workforce model which effectively eliminates the older, more traditional validation approach.  
  • Accelerated Pace: Novel drugs and biologicals are being approved quickly due to the FDA’s innovative efforts and efficiency improvements, such as adaptive clinical trials. A better understanding of disease and drug mechanisms has bolstered the development of new targeted therapies. And approval of medical devices has surged at an unprecedented level as consumers embrace wearables of all sorts. Today, even the applications in your cell phone might be classified as FDA-regulated medical applications. These products are coming to market quickly but must first undergo rigorous validation efforts before patients can enjoy their benefits.
  • Emerging Technology: The adoption of DevOps tools enables companies to address the ongoing release of enterprise software and its integration into critical applications to the business. Agile-oriented software development teams (that reject a waterfall approach to SDLC) are dictating the technology of the future, which challenges traditional life sciences quality assurance personnel comfort zone.
  • Systems Which Lack and Enterprise-Wide View of Compliance Risk: Life sciences – just like most other industries – have grown up with a siloed infrastructure, one that is filled with separate, individual business units and operational areas. Many of these departments do not talk to each other, let alone collaborate with one another.
  • Mergers and Acquisitions: While the last couple of years may not measure up to the mega-merger deals of previous years, continued merger activity can be problematic in terms of multiple – and often redundant – systems, non-integrated processes, and differing procedures/processes.
  • Economic Pressures: Faced with increasing pressure to maintain competitiveness by shortening development timelines and reducing costs, companies are finding they can no longer afford the inefficiency of lengthy, resource-constrained, and manually laden validation processes.
  • Outsourcing and Sub-Contracting: More and more companies are outsourcing major corporate functions such as research, product development, and manufacturing, which further strains the ability of current infrastructures and systems to integrate test procedures while maintaining control and consistency across multiple partners/multiple sites.

  • Changing Regulatory Environment: Life science companies are already heavily regulated by a number of organizations including the FDA, the EMA, the ISO, just to name a few. The industry is also affected by non-FDA-type regulations such as Sarbanes Oxley and General Data Protection Regulation (GDPR). All these regulations routinely evolve to protect the interests of industry and consumers.

  • Rise of Computer Software Assurance (CSA): As the FDA continues to modify its regulatory approach to life sciences companies, greater emphasis is being placed on the CSA model - effectively changing the organization’s approach from compliance/documentation dominated focus to a quality-driven proposition, wherein compliance is achieved and captured in a more measured way through critical and strategic thinking based on risk. While this new guidance helps to streamline documentation and promote patient and product safety/quality assurance, it also helps to drive greater utilization of technology and automation. 

As I’m sure most of our readers can attest to – likely having come from a document-centric background or being currently embroiled in a document-based framework – it’s easy to see how these mounting changes over the last number of years have really driven organizations, industry thought leaders, and even regulatory bodies to shift away from traditional validation practices. As with business drivers in any industry, when the roadblocks continue to mount, better methodologies and tools are developed to allow for adaptation. While evolution is certainly beginning to take place, many teams are still unsure of what it actually looks like for their organization, or how to embrace it.

This is where the Digital Validation approach comes into the picture, but it’s a bit too much to unpack here. Instead, in an upcoming post, I’ll go more in-depth in discussing what it actually is as well as the benefits it offers as life sciences teams adapt and transform to meet modern demands.

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