2024 Validation Insights: Setting the Course for 2025 Success

Welcome to the final 2024 edition of Validation Nation, where we bring you the essential highlights from this year’s State of Validation industry report. The report, crafted by life sciences market research expert Jonathan Kay, captures a comprehensive overview of industry trends, challenges, and transformative shifts.??

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If you’re looking to keep your validation practices ahead of the curve in 2025, the report’s insights are invaluable.??

Be a voice for change in 2025 — sign up now to participate in next year’s State of Validation survey and help shape the future of validation practices in your industry!?

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Here’s a glimpse into each key section of the 2024 report, along with additional resources to help deepen your understanding.?

People and Organizations?

In this foundational section, the report explores how validation teams are structured and the industry demographics, including salaries and team size. It reveals a diverse range of experience levels within validation teams, creating opportunities for mentorship and skills-sharing. While larger organizations continue to support robust validation teams, smaller teams are becoming more agile to handle dynamic demands. For professionals, this means continued growth and a need for cross-functional capabilities.?

Key takeaway: Developing a balanced team structure enhances resilience and adaptability. Organizations should leverage both veteran and new talent to keep pace with evolving requirements.?

In this blog article, we delve into key trends found in the “People and Organizations” section of the 2024 State of Validation report, highlighting team sizes, salaries, experience levels, and outsourcing trends.?

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Validation Programs?

This section dives into the different validation program models. Notably, the report found that site-specific validation structures remain popular but are increasingly complemented by process-driven and centralized systems. Additionally, the adoption of Computer Software Assurance (CSA) is gaining traction, indicating a shift toward more streamlined, risk-based validation processes.?

Key takeaway: As organizations advance their validation practices, centralizing workflows where possible can drive efficiencies while reducing redundancies.?

CSA is an innovative new way to meet CSV compliance requirements, but you’ll need a robust understanding of its principles and pitfalls to implement it successfully. In this guide, How to Adopt CSA for Streamlined Computer System Validation, you’ll learn about CSA, why it will bring your CSV programs to their next level, and how you can bring it to your validation program quickly and easily.?

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Goals and Growth?

What does growth look like in validation? According to the report, there is a strong push for process efficiency and continuous audit readiness. Top goals include implementing new validation technologies and harmonizing practices across sites. Additionally, validation teams are focusing on developing their audit readiness, aiming for fewer deviations and improved cost efficiencies.?

Key takeaway: Prioritizing efficient and harmonized validation practices can lead to more consistent outcomes and regulatory success. Investing in new technologies and data management tools also provides long-term value.?

When you’re in a highly regulated industry, you’re going to be audited — are you ready? In our eBook, Audit Preparedness: Using Digital Validation to be Ready for Anything, Kneat’s audit expert Joe Azzarella explains everything you need to know to make sure you can respond to any question, demonstrate compliance, and breeze through your next inspection.?

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Industry Change and Digital Transformation?

Digital transformation continues to impact validation, with remote audits and increased automation reshaping the landscape. Digital validation systems are predicted to play a pivotal role in the coming years. This technological evolution brings opportunities for improved compliance as well as data integrity and resource allocation.?

Key takeaway: Embracing digital tools and automation is critical to staying competitive. Validation teams should focus on integrating these tools to enhance rigorous data integrity standards.?

In The Digital Validation Handbook: Your Guide to Faster, More Accurate Validation, you will find out everything you need to know about how to streamline validation, leave paper-based processes behind, mitigate noncompliance risks, and drive more value for your company.?

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The Future of Validation?

Looking forward, the report anticipates greater reliance on AI, automation, and Pharma/Industry 4.0 tools. These technologies, including robotics, cloud computing, and data analytics, will be instrumental in reducing workload, enhancing audit readiness, and supporting sustainability goals within validation programs.?

Key takeaway: Preparing for the future means embracing innovation. Validation teams should prioritize adaptability, cross-functional collaboration, and upskilling to harness the full potential of emerging technologies.?

Take your paperless validation skills to the next level with Kneat Gx software training from Kneat Academy. Courses include Customer Onboarding, Administration, End User, Power User Level 1, and Power User Level 2. Partners can progress to our Super User program. Open Day courses, available for individual enrollment, run monthly.???

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Get Your Validation Program Ready for 2025?

To explore these themes further and get your validation program ready for 2025, here are some additional resources for you.?

Exploring Recent Developments in Pharmaceutical Validation???

This Executive Summary — developed by leading pharmaceutical industry publisher Pharma Executive — provides actionable insights from the 2024 State of Validation for validation professionals aiming to optimize validation programs, streamline processes, and stay competitive in a fast-evolving pharmaceutical landscape.?

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2024 State of Validation: Insights & Trends?

Watch our on-demand webinar, featuring discussion and analysis of the 2024 State of Validation findings — by validation experts Art Gehring , Adolfo Santana , JoonLeong Ng , and Justin Blackwelder — from the report's executive sponsor Kneat Solutions and supporting organizations BW Design Group , No deviation , and PCI - Calibration, Commissioning and Consulting .?

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Season’s Greetings from Validation Nation!?

As we close out another year of insights and advancements, we want to wish all our readers a very merry holiday season filled with joy, relaxation, and inspiration for the year ahead. Thank you for being part of the Validation Nation community. ???

Subscribe and stay tuned in 2025 as we continue to unpack the latest trends, challenges, and innovations shaping your industry!?

Wrap up the year with the gift of streamlined validation — book a demo today and see how Kneat Solutions can make your processes merry and bright!???

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