Top Priorities for Validation Teams in 2023
The State of Validation survey asked validation leaders to define their major priorities for 2023, with some interesting results! Understand some of the key goals and priorities for validation professionals in 2023, why teams are focusing on them, and how Kneat’s dedicated digital validation training institute, Kneat Academy, can help you achieve these goals too.
Validation’s Key Goals in 2023
Most Prevalent Validation-Related Goals: State of Validation Report 2022
Creating process efficiencies is the top priority for validation teams today, followed by right first time/minimizing deviations, and upskilling validation teams.
Robust data integrity also ranked highly—in line with a growing appetite for better quality and more comprehensive data. Another key priority highlighted is reducing costs, with teams looking to earn a better return on investment (ROI) of their validation programs and determine whether they are driving efficiency for the organization. Learn more about the trends influencing validation professionals today in the State of Validation report.
1. Creating Process Efficiencies
The most prominent goal for validation teams in 2023 is ‘creating process efficiencies’, selected as the number one focus for the year. Validation can be an onerous, inefficient process—one which translates into increased costs for the business and can undermine an organization’s competitive edge in the market. Additionally, inefficient validation can also act as a ‘bottleneck,’ preventing products from reaching the market in a timely manner. So, it is understandable that teams focus on core goals of lean validation that also create value.
A prominent example of a lean best practice is process digitization. More and more companies continue to embrace technology and realize that the digitization of their validation process is a value-added endeavor.
Nearly 80% of survey respondents indicated that they are using technology to support their validation work processes. Conventional paper-based validation processes and systems are proving to be a major frustration, slowing down lifecycles, wasting resources, and increasing the risk of making errors with respect to compliance. Removing paper from every stage of the validation lifecycle is undoubtedly a lean best practice.
Kneat is proven to cut validation cycle times and labor hours in half. Learn more about how process digitization with Kneat delivers greater long-term value to your business.
2. Minimizing Deviations
Another way to progress process efficiencies is by enhancing a ‘right first time’ approach through minimizing deviations, so it is promising to see this rank second as a top priority.
Although it is essential for any validation project to manage defects or deviations which may occur during test preparation and execution—the tracking and management of deviations is also one of the largest culprits of waste production. Whether it be the tracking and management of deviation forms associated with test protocols or transferring information from a deviation form to a corrective action report, it is a significant drain on resources.
Streamlined paperless validation processes can have a substantial impact on a business by enabling more right-first time through creating projects and documents using pre-defined templates—which enforces consistency across teams—as well as greater productivity, shorter cycle times, and a higher compliance standard.
Kneat Gx allows users to electronically create, approve and execute all records, manage any exceptions, and post-approve the final executed records and reports in a controlled FDA 21 CFR Part 11 / EudraLex Annex 11 paperless compliant system.
Learn how a leading molecular diagnostics company uses Kneat to speed up CSV validation to meet increased productivity and compliance demands.
Client Story:
A Leading Molecular Diagnostics Company
A Leading Molecular Diagnostics Company
The client is a leading molecular diagnostic company dedicated to saving and improving lives by discovering and delivering tests across major diseases. They produce their own proprietary software which requires validation and FDA compliance and have been successfully using Kneat since 2014.
READ STORY3. Upskilling the Validation Team
Most Important Future Skills for Validation Professionals: State of Validation Report 2022
Survey respondents were asked to select all skills and/or attributes they thought validation professionals would need to best match how validation is performed. Looking ahead, validation professionals see greater technological skills as the top priority, followed by improved adaptability, and improved project management skills, highlighting specific training content types as a method to build those skills.
Educational Content Preferences of Validation Professionals: State of Validation Report 2022
Validation leaders and managers could benefit their teams by providing training and educational content in the form of internal webinars and training workshops and courses, to address topics of technology skills development, regulatory change, validating new technologies, adapting to organizational change, and how to better manage validation projects. The provision of training in these areas would benefit longer tenured validation professionals, most impacted by the shift to technical validation practices.
Training the Future of Validation
Founded in 2020, Kneat Academy is dedicated to training the future of validation through a robust syllabus of certified Kneat Gx courses. Kneat Academy provides training for all competency levels, from fundamental to advanced, for students to seasoned professionals.
Each course provides the practical, hands-on experience and competencies required to attain Kneat Academy certification and perform specific user-roles in real-world organizations. Enroll at Kneat Academy to train for your validation future today.
Syllabus Structure: Kneat Academy
End User Certificate in Kneat Gx Skills
Gain a new qualification in key fundamental skills and best practice techniques in digital validation processes, using the basic features of Kneat Gx with Kneat Academy’s self-paced, online, End User course. Designed for new Kneat Gx users, you will develop essential skills like general navigation, document development, review and approval, and execution on the Kneat Gx Platform.
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“The End User Certificate program was surprisingly robust, and really helped me hit the ground running with Kneat Gx after it was implemented at our site.”
– End User Trainee
About the Author
Lisa Wright, BA, GDL – Content Writer, Kneat
Lisa is an experienced writer whose work is focused on contextualizing the challenges and opportunities for validation, quality assurance, and compliance professionals operating in highly regulated industries. Outside of the office, she’s committed to education and has completed Kneat Academy End User and Power User 1 digital validation software training.
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