Three Key Validation Trends in 2023
No industry stays completely the same year over year, even one as cautious in change as the validation industry. In the past, it’s been difficult to monitor changes in validation as few professionals identified as being a “Validation” professional. Many are more inclined to state “Life Sciences” or “Consumer Packaged Goods” as their industry bloc, but, with so many similarities in validation activities and challenges connecting professionals across manufacturers, that’s starting to change.
In 2022, Kneat Solutions launched the inaugural State of Validation report, drawing on the insights and experiences of validation professionals across multiple industries, geographies, and demographics. Later that year, VALIDATE, Kneat’s first-ever conference designed for validation professionals, brought together leaders from around the world to share experiences and learn together.
In doing so—carving out the validation subindustry from broader ones—we’ve been able to identify three key trends that will impact professionals involved in the crucial activity of validation.
Most industries highlight digital transformation as a key goal for the near future, but few have remained so dependent on manual, paper-based systems as the validation industry. In the 2022 State of Validation report, 21% of respondents said their company was completely dependent on paper-based work processes, and a further 65% said they used a mix of paper-based and digital systems. It’s no wonder then that the U.S. Food and Drug Administration (FDA) established its own Office of Digital Transformation (1) in late 2021 and continues to focus on this effort.
In September 2022, the FDA produced guidance on Computer Software Assurance (CSA) (2) which it viewed as supplemental to the long-held regulatory requirement of Computer System Validation (CSV). In the guidance, it stated that the life sciences industry had been too slow to adopt innovative technologies. It also set up a Modernization Framework (3) to focus on developing and implementing technology and data for better business outcomes.
Among these technologies, digital validation is expected to see a significant increase in adoption with 45% of companies surveyed in the 2022 State of Validation Report stating they plan to adopt digital validation in the new year. Digital validation is both an example of digital transformation, and an enabler of it; when applied to computer systems validation and computer software assurance work processes, digital validation is proven to halve cycle times and labor-hour costs.
Further, as digital transformation continues to gain momentum throughout 2023, the number of computer systems required in production and quality assurance will expand placing greater time and workload pressures on computer systems validation teams. In 2022, computer system validation was cited as the most frequent of all work processes encountered by respondents of the 2022 State of Validation Report – a trend expected to magnify in 2023.
Digital validation has several benefits compared to paper-based or hybrid systems, including:
- Lower overhead with reduced need for paper and subsequent storage.
- Faster validation (Kneat has proven to reduce cycle times by as much as 60% compared to paper programs).
- Improved data integrity and accuracy.
- Improved transparency for managers.
- Automated audit trails.
- Flexibility for work arrangements, including the ability to work remotely.
Human Resources Challenges
Everywhere, people are being asked to do more, with less. In the 2022 State of Validation survey, 74% predicted workloads would increase, but the majority didn’t expect a significant increase in team size—a trend continuing from 2022 where 80% stated workloads increased while human resources remained unchanged.
Despite this challenge, budgets are expected to increase with greater emphasis being placed on using tools like digital validation to manage growing workloads effectively. Using available tools, such as Kneat Gx, which allow for leaner work processes, due to the inherent time-savings experienced by removing paper from workflows in addition to streamlining process steps including protocol generation, review and approval, test cases, trace-matrices, and audit trails.
From a regulatory standpoint, the FDA is also making efforts to reduce the risk and burden of high workloads and ensure quality, at least in the area of computer systems validation, with their September 2022 draft guidance on Computer Software Assurance which encourages organizations to scale validation effort proportionally to risk. You can read Kneat’s CSV expert Darren Geaney’s CSA tips here.
Validation Data Analytics
For validation, especially in the highly regulated life sciences sector, the saying has always been “if it isn’t documented, it didn’t happen” but the industry can’t rely on documentation alone. Data and documentation must go hand in hand for companies to identify opportunities for improvement or spot risks before they harm operations. First, some key distinctions:
- Data is factual information (think measurements or statistics) that’s used for analysis or calculation.
- Documents are collections of texts and entity data.
To gain the insights afforded by data, companies will first need to adopt digital technologies needed to generate reliably accurate data, from which to analyze. The application of data analytics technologies to validation data, or through advanced in-application reporting, has the potential to transform efficiency, cost-effectiveness, and risk profile of quality assurance and build a new high-water mark in value creation for the discipline.
With more data available, however, management can be challenging, and confusing to identify data points which can support actionable insights, versus contextual (metadata) or simply irrelevant data points. It also brings new challenges and requirements in data architecture, systems integrations, and data governance.
As discussed by Sean O’Leary, Head of Engineering Programs, Takeda at Kneat’s validation industry conference VALIDATE 2022, the concept of ‘Data Quality’ will grow in importance in 2023. Distinct from Data Integrity, which is the reliability of the information regarding it’s physical and logical validity (e.g. was it falsified, or was it a real entry?), Data Quality is the reliability of information to serve an intended purpose or goal (e.g. to reduce the deviation rate below a target). Data quality is characterized by an array of key data points, and contextual ones to enable an actionable insight to occur. It requires a clear data governance and management strategy, complete with goals, so that throughout the lifecycle of a validation process all required data is captured to support analysis.
The design of work processes and setup of protocols is critical to supporting the capture of relevant data and requires a system that has an appropriate level of flexibility at the design stage, while providing a set workflow for execution.
Kneat uses configurable, controlled templates to make user’s data input and attachment, quick, easy, and aligned with your data governance strategy. Documents are connected so data can be automatically edited wherever they need to be, and users can easily navigate from one to another, without the need for cumbersome retrieval of boxes and binders.
Join validation expert and Kneat’s Director of Strategic Partnerships Rick Mineo on Tuesday, January 17, 2023, for the webinar “Shifting Focus From Documentation to Data” and discover:
- Why you should switch from documentation to data, including metadata, entity data, consuming data, and the asset data lifecycle.
- The importance of data integrity including governance, scoping, mapping, research, staffing, and training.
- How to create a data model from development to implementation, maintenance, and future state.
How Kneat Helps
Kneat is the leading digital validation solution, used by eight of the top 10 pharmaceutical companies. Kneat Gx streamlines validation for multiple work processes all in one, intuitive platform. See for yourself how we’ve helped reduce cycle times by over 60% in our client stories.
About the Author
Tristan Worden – Senior Content Marketing Strategist, Kneat
Tristan has over a decade of experience communicating complex ideas to both general and specific audiences with almost five years in the compliance and validation sector. He is passionate about ensuring validation professionals have the information they need to do their jobs effectively.
- FDA – Office of Digital Transformation’s New Focus on Technology Leadership, [https://www.fda.gov/news-events/fda-voices/office-digital-transformations-new-focus-technology-leadership].
- FDA – Computer Software Assurance for Production and Quality System Software, [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software].
- FDA – Technology and Data Modernization Action 2022, [https://www.fda.gov/news-events/fda-voices/fdas-technology-and-data-modernization-action-2022].
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