Validation Nation

Data Integrity Decoded: Essentials for Validation Pros 

At Kneat, we are committed to supporting organizations through their digital transformation, equipping teams with the tools and knowledge to enhance their validation processes. To help you stay ahead, we’ve curated this monthly newsletter with valuable validation resources and industry insights. 

This edition dives deep into the critical topic of data integrity, a cornerstone of compliant and secure validation processes. Professionals in validation and quality roles within life sciences and other tightly regulated industries need a solid grasp of data integrity, its regulations, and the well-known acronym ALCOA+.  

To get started, explore our latest resource, The Data Integrity Handbook, written by data integrity expert Olivia Calder. This eBook explores the evolution of data integrity and explains how to ensure effective, compliant, documentation throughout your entire manufacturing lifecycle. 

👉 Read eBook 

- Eddie Ryan, CEO, Kneat 

ALCOA++ 

Even those confident in their knowledge might be intrigued by a new concept that emerged in 2023: ALCOA++. This enhanced framework, marked by the two plus signs, extends the core principles of data integrity.  

The additional "+" represents a further emphasis on traceability. At a high level, a traceable document is one with a serviceable audit trail, with a clear line of activity which may include such actions as: 

• When was the document reviewed last? 

• How is it stored? 

• Was the document revised? 

• Why was the document revised? 

As regulatory expectations rise with the advent of ALCOA++, ensuring the accuracy and traceability of your records is more essential than ever. 

In ALCOA++ and the Future of Data Integrity, Olivia breaks down the ALCOA++ framework and what it means for the future of data integrity in validation processes. Learn how your organization can implement these principles effectively to ensure regulatory compliance and robust data governance. 

👉 Watch the Webinar 

2024 State of Validation 

Kneat is proud to sponsor the annual State of Validation Report, an in-depth look at the current trends and challenges faced by validation professionals across the life sciences industry. 

2024 Key Data Integrity Findings: 

• Data Integrity a Rising Concern: Data integrity has steadily become more critical over the last three years, reflecting the growing emphasis on reliable and secure data in validation processes (see table below). 

• Benefits of Digitalization: Data integrity is ranked as the highest benefit, emphasizing the critical importance of accurate and reliable data in the validation process. This underscores how digital tools ensure validation data remains precise and trustworthy. 

• Primary Goals: Robust data integrity and upskilling the validation team are identified as important goals of validation programs, emphasizing the need for reliable data and continuous professional development. 

Authored by life sciences market research expert Jonathan Kay, this report is packed with valuable insights, benchmarks, and year-over-year trends that can guide your organization’s validation efforts in 2024 and beyond. 

👉 Download the Full Report 

Continuous Professional Development at Kneat Academy 

Since its inception, Kneat Academy has helped over five thousand professionals sharpen their digital validation skills through tailored programs. Here's a short overview of two courses available to upskill and empower your team to excel in digital validation. 

• End User: A self-directed online course covering essential skills, including document development, review and approval workflows, test execution, and entity management. 

• Power User Level 1: An instructor-led online course for intermediate users, focusing on document templates, approval workflows, and report configurations. Completion of the End User course is required. 

With Kneat Academy’s comprehensive learning paths, you can ensure your team is equipped with the skills needed to streamline validation processes and ensure compliance. 

👉 Learn More About Kneat Academy 

Spotlight on VALIDATE 2025: What to Expect

We are thrilled to announce our annual VALIDATE 2025 conference will be held in Boston, MA, on April 30-May 1, 2025. This year’s theme, ‘Accelerating Digital Maturity,’ will focus on how validation professionals can fast-track their digital transformation journey. Join experts from across the globe as we explore trends, challenges, and innovations shaping the future of digital validation. 

👉 Register for VALIDATE 2025 

Check out our VALIDATE 2024 recap video for a sneak peek at what’s in store at VALIDATE 2025. From insightful panel discussions to hands-on workshops, it’s the must-attend event for anyone in the validation space. 

👉 Watch the Video   

Thank You 

Thank you for reading our newsletter. Don’t miss out on the trends and innovations that can transform your validation processes. Subscribe to Validation Nation now and be part of the conversation!