2025 Life Sciences Trends – A Perspective for QA and Validation SMEs

The life sciences industry is on the brink of major technological change in 2025, and Information Technology (IT) is no longer just a support function—it’s at the heart of everything, from innovation to compliance. As QA and Validation SMEs, this evolution is an exciting opportunity to redefine how quality and compliance align with business goals. With priorities like risk management, IT strategy, and cutting-edge technologies such as AI taking center stage, there’s never been a more important time for QA professionals to step up as strategic enablers.

Below, we explore the latest trends shaping our industry based on Gartner’s 2025 CIO Agenda: Top Priorities and Technology Plans for Life Sciences?(September 2024).

1. Cybersecurity and Risk Management: The Cornerstone of IT Strategies

In 2025, 90% of life sciences organizations?are increasing investments in cybersecurity. This aligns with the sector’s emphasis on mitigating risks associated with sensitive patient data, intellectual property, and compliance with rigorous regulatory standards such as GxP.

Gartner highlights that cybersecurity investment in life sciences ranks among the highest priorities across industries, with 90% of organizations increasing funding in this area.

Why this matters for you: In some way, QA and Validation SMEs are uniquely positioned to make a difference. We are the go-to expert in ensuring systems are validated and compliant. Now, your expertise will naturally extend to safeguarding these systems against cyber treats, aligning IT security with every regulatory standard we work with.

What can you do:

• Collaborate closely with IT to ensure quality systems are both secure and compliant.
• Integrate cybersecurity assessments into validation protocols to proactively address risks.
• Stay on top of evolving regulatory guidelines for digital security, empowering your organization to meet compliance expectations.

By proactively integrating cybersecurity into validation processes, you can position yourself as an essential player in mitigating risks and ensuring compliance. This shift allows you to expand your expertise beyond traditional quality roles into the strategic domain of IT security.

2. Strategic IT Alignment: From Back-End Support to Business Driver

IT is now a core driver of business value, and as a QA and Validation SMEs, your role will be critical in aligning quality assurance objectives with broader IT strategies. For CIOs, modernizing applications and proving the business value of IT are top priorities:

• Creating and executing IT strategies (61%).
• Demonstrating the business value of IT (50%).
• Modernizing enterprise applications and software (50%).

Gartner's CIO focus areas for 2025 in life sciences emphasize the integration of IT strategy with business objectives, showcasing a shift in how CIOs view their roles as strategic enablers.

Why this matters for you: Your insights and expertise are invaluable when IT teams discuss aligning systems with business outcomes. By integrating validation activities into early-stage IT planning, you can prevent costly rework and ensure compliance from day one. This isn’t just about supporting IT. It’s about influencing initiatives and demonstrating how a strong validation strategy drives both compliance and business success.

What you can do:

• Collaborate on adopting IT systems that enhance quality control and quality assurance, such as an electronic Quality Management Systems (eQMS).
• Advocate for the integration of validation activities into project planning, ensuring compliance is a built-in feature, not an afterthought.
• Leverage IT strategies to align quality assurance with key business objectives, showcasing how your work contributes to operational and financial outcomes.

3. The Role of AI and Generative AI in Life Sciences

With Generative AI (90%) and Artificial Intelligence (88%) topping investment priorities in 2025, the life sciences sector is leveraging these technologies to enhance innovation, streamline processes, and improve decision-making. As exciting as this is, we know that incorporating AI into your systems can feel daunting, especially with the complexities it brings.

According to Gartner, life sciences organizations are among the top adopters of Generative AI, reflecting its transformative potential in areas like drug discovery, clinical trials, and personalized medicine.

Why this matters for you:?These technologies can transform how processes are managed, but they also need to be reliable and compliant. As a QA or Validation SME, this is your chance to take the lead in making sure AI systems meet industry standards and best practices. Your expertise ensures these tools produce consistent results and stay within regulatory guidelines. By using AI, you can also automate repetitive tasks, giving you more time to focus on higher-priority work.

What you can do:

• Lead the validation of AI and Generative AI systems to ensure they are compliant with industry regulations and deliver reliable outcomes.
• Collaborate with IT to integrate AI into quality and compliance workflows effectively.
• Identify tasks that can be automated using AI, such as deviation management or audit trail reviews, to improve efficiency.
• Stay informed about the evolving regulatory landscape for AI to keep your organization compliant and ahead of potential challenges. Help you validate AI tools, ensuring they meet compliance standards while unlocking their full potential for your organization.

4. Low-Code Platforms and Digital Transformation

The adoption of low-code/no-code platforms (46%) highlights the sector’s push to enable operational teams to develop and deploy solutions quickly, reducing reliance on IT while accelerating innovation. These platforms are transforming how organizations tackle quality and operational challenges, creating opportunities for more agile responses.

Gartner data indicates that life sciences organizations are adopting low-code platforms to streamline workflows and increase operational efficiency while maintaining compliance.

Why this matters for you: We know these platforms can be a game-changer for your day-to-day work. They empower you to create workflows and solutions without waiting for IT support, saving time and effort. But here’s the challenge: even with their simplicity, these tools must be validated to ensure compliance when used in a GxP context. That’s where your expertise come in.

What can you do:

• Take the lead in understanding how these platforms can fit into your workflows and identify opportunities to streamline processes.
• Collaborate with IT and quality teams to ensure compliance standards are built into the use of these platforms from the start.
• Advocate for proper training and guidelines within your organization to make the most of low-code/no-code capabilities.

5. Critical Outcomes of Technology Investments

Life sciences organizations are strategically investing in technology to achieve key outcomes, including:

• Improved operating margins (96%).
• Compliance and risk minimization (91%).
• Enhanced customer experience (84%).

Gartner reports that improving operating margins and minimizing compliance risks are the two most critical outcomes of digital technology investments in life sciences.

Why this matters for you:?You’ve always worked hard to improve efficiency while keeping everything compliant. Now, these goals are more important than ever for your organization. This is your chance to push for systems and processes that not only meet compliance but also add real value to the business. By showing how quality can improve operations and customer results, you can become a key partner in driving the company’s success.

What can you do:

• Highlight the value of adopting advanced systems, like electronic Quality Management Systems (eQMS) or real-time analytics tools, to achieve both compliance and efficiency.
• Collaborate with IT and leadership to ensure quality objectives are integrated into technology initiatives from the start.
• Use performance metrics to showcase how quality improvements contribute to broader business goals, such as cost savings or customer satisfaction.

6. Preparing for Technological Modernization

Technological modernization is more than just a trend—it’s a reality reshaping the life sciences industry. With Artificial Intelligence (49%) and Generative AI (59%) steadily becoming standard, organizations are leveraging these advancements to optimize manufacturing processes, streamline validation, and enhance data integrity.

Gartner highlights that life sciences organizations are among the leaders in deploying cutting-edge technologies like AI and generative AI to modernize processes and enhance decision-making.

Why this matters for you: We know you’re familiar with navigating change, and this shift is an opportunity for you to lead. Modernization provides the tools to enhance quality systems while staying ahead of regulatory demands. By engaging with these technologies, you can align compliance with innovation, making a significant impact on your organization’s success.

What can you do:

• Partner with IT to validate advanced systems, ensuring they meet both compliance and operational goals.
• Take the initiative to upskill in emerging technologies so you can confidently contribute to discussions about innovation and quality.
• Advocate for integrating compliance into the early stages of deploying modern systems, avoiding costly delays or rework.

In conclusion, the message is simple: 2025 is about balancing innovation and compliance in the life sciences sector.

As a QA or Validation SME, this means adapting to new tools like AI and low-code platforms while staying focused on compliance. Your role is more than maintaining standards. You can help your organization use technology to stay competitive and strong in a fast-changing world. By working with IT teams, using new tools, and focusing on quality, you can make a big impact.

The future is here—let’s move forward together!