State of Validation

CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey.  The survey targets current professionals in a validation, quality, or compliance function in industries governed by Data Integrity or ICH, FDA, and EU GMP Guidelines. This year’s survey results concluded that the trends toward digitization of validation processes continues. Of the respondents surveyed, 54% stated that their company now uses an internal or 3^rd party digital tool to manage validation processes. This number is up 42% from the 2022 survey response and shows the rapid progress the industry is making towards digitizing validation processes.

Despite the overall progress in this area, the overall digitization of processes is heavily influenced by large companies that are approaching full adoption, while small to mid-sized companies are still struggling with the resource costs of implementing digital solutions.  Most respondents agree that digital validation solutions provide the most significant opportunity to improve validation processes in the coming years, with 9 out of 10 respondents stating it would have the greatest impact on future validation. If the industry is to continue towards full adoption of digital validation, solutions will need to be created to enable small to mid-sized companies to overcome the resource constraints, both human and capital.

CAI is working to address these constraints by offering out-of-the-box solutions using the Kneat Gx platform.  CAI’s Project Ready subscription service allows customers to execute full projects in a shared environment of Kneat Gx with access to all of CAI’s best-in-class templates and built-in validation processes. Head Start offers customers their own Kneat instance as a hosted subscription service.  The Head Start subscription comes complete with CAI’s best-in-class templates and validation processes.  Both options reduce the number of front-end resources required to build a digital solution along with the ongoing overhead of maintaining such solutions.

Data Analytics and Machine Learning in validation processes come only slightly behind digital validation solutions in expected future impact, with agreement by 8 out of 10 respondents. The majority of those who responded in this manner have already implemented digital validation processes.

What can we conclude from this data? The industry has recognized efficiencies to be gained by moving from paper-based and manual validation processes towards digital.  A significant number of companies have digitized validation processes over the past 2 years, primarily larger companies with the human and capital resources to undertake such projects.  For these companies, we can also now see a recognition that a significant amount of data is available to them that was previously locked away in paper documentation.  The next step for these companies is to begin to adopt Data Analytics and Machine Learning to unlock the power of this data.  At CAI, we are working to turn Validate into ValiDATA by exploring the latest trends in Digital Twins, Augmented Reality, and Artificial Intelligence.  Using these technologies to connect data sources, analyze data trends, and present data understandably will get the right data to the right people at the right time. This will truly transform how validation is done and unlock the value it can provide to the industry.