Bryan Ennis is the CEO and cofounder of Sware, a regulatory technology company serving healthcare, life sciences and SaMD companies.
“The measure of intelligence is the ability to change.”
This famous line is highly relevant in today’s evolving digital landscape. For life sciences chief information officers (CIOs), digital validation is often treated as an afterthought. However, validation is an integral part of the foundation of any life sciences business. Although CIOs are not responsible for compliance workflows, they do have the opportunity to implement systems that automate processes and digitize the end-to-end compliance chain to lower their systems implementation and maintenance costs and to reduce the burden on their teams.
This dynamic is more vital than ever before with the industry-wide transformation to Pharma 4.0. For CIOs wanting a competitive edge, I believe compliance must be understood as an imperative to your organization’s success. This is where Validation 4.0 comes in. Validation 4.0 is “a holistic and integrated approach to validation and the future of compliance across regulated industries.” This new form of validation workflow is the compliance engine that instills trust and quality in the new technologies of Pharma 4.0.
With that in mind, here are three ways for CIOs to prioritize Validation 4.0 in their organizations.
1. Dismantle organizational silos and empower the exchange of information.
Validation and compliance are often assigned as the responsibility of the quality team, who are tasked with ensuring the organization remains current with the latest guidance from regulatory agencies. But validation is an industry mandate that affects the entirety of the organization. To ensure the business is operating at its most efficient and productive capacity, the broader organization should be involved in the validation lifecycle to dismantle silos, improve processes and facilitate the exchange of information across teams.
Most organizations are structured by IT, quality and business teams. These teams often don’t communicate with one another, and when they do, they’re speaking different languages and have different goals. The CIO needs to bridge the gaps between these three teams and serve as the translator in the transition to Validation 4.0.
New technologies of Validation 4.0 can relieve your organization of the legacy validation burden that is over-testing and over-documenting. To put it simply, modern technologies focus on quality versus quantity, which benefits a variety of teams—not just the quality team. These technologies help IT optimize resources; support the quality department in guiding, monitoring, and measuring quality of products; and increase efficiency across the business. By dismantling silos and involving all three teams in the validation workflow, you should see significant efficiency gains.
2. Keep all team members informed.
Historically, the industry has followed the practice of Computer System Validation (CSV), which is largely manual, primarily paper-driven and resource-intensive. However, more recently, the industry has begun a transition to Computer Software Assurance (CSA), an approach that applies critical thinking and the consideration of risk by focusing on what matters most: patient safety, product quality and data integrity. The progression to CSA can save valuable time and resources and bring business, quality and IT teams together to make their lives easier.
As more team members become involved in the validation process, it’s imperative that they’re kept updated on the latest regulations and requirements and that they recognize the broader implications of remaining in compliance. For example, teams should understand data across their systems and the requirements necessary for validation and compliance. By digitizing this process—under the CIO’s leadership and strategy—teams can more easily perform system risk assessments, track validation efforts needed at the system requirement level and monitor risks across systems sharing the same requirements. This is particularly important in mitigating risk and maintaining accurate, up-to-date and audit-ready records.
Since the IT and business teams have historically been distanced from the validation lifecycle, most feel like their time is being wasted by lengthy validation processes. However, a Validation 4.0 approach enables CIOs to articulate the impact on the wider business strategy and objectives and streamline efforts across the board.
3. Limit resource constraints.
Most life sciences organizations struggle with resource constraints, and as regulatory conditions become increasingly cumbersome, quality teams often turn to additional resources, tapping external team members or contractors for support. This disrupts workflows and entangles resources. According to the Randstad 2022 Talent Trends report, “One-third of C-suite and human capital leaders in the life sciences and pharma sector say talent scarcity is a major pain point.” To mitigate negative impacts, CIOs must remain informed on team resource constraints, identify overlap among teams and ultimately establish resource harmonization.
Like most industries, the pace of growth and innovation in life sciences has outpaced the number of people available. However, with the new wave of technology solutions brought on by Validation 4.0, there is an incredible opportunity to optimize resources and limit waste. In fact, “Approximately 30% to 40% of validation documentation creation time is saved, decreasing time to market” and accelerating the speed to value by reducing the time to maintain and validate systems. This helps get products to patients faster by making teams more efficient with applications they depend on to get the job done.
Prioritizing Validation 4.0 To Work Better, Smarter And More Efficiently
Too often, validation becomes a barrier to innovation in life sciences because of the time and resources required. However, validation and compliance impact the success of the entire company. It’s the responsibility of the CIO to set the tone across the organization with respect to the business benefits of digitizing the validation process and to support integrations with existing compliance and testing infrastructure.
CIOs are uniquely positioned to integrate new Validation 4.0 solutions and bring teams together to make the end-to-end validation process far simpler and more effective, all while saving the company a significant amount of time, money and frustration.
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