In the highly regulated world of life sciences, organizations must adhere to guidelines such as the FDA’s Draft Guidance for Computer Software Assurance (CSA), ICH-Q9, and GAMP 5. Consequently, there is a constant drive to optimize validation processes.
Traditional validation efforts often involve excessive documentation and testing of every component of a system or piece of equipment. This can lead to overburdened teams, wasted resources, and delays in getting products to market. However, requirement-level risk assessment is transforming how organizations approach both software and equipment validation, streamlining efforts while maintaining compliance and product quality. This approach enables businesses to focus on what matters most, ensuring systems and equipment function safely and effectively, without unnecessary complexity or overhead.
In this blog post, we'll explore why assessing risk at the requirement level is a game-changer in validation and how it can significantly improve your digital validation strategy.
Historically, the validation of equipment and software has involved testing and documenting everything as a standard practice. While this approach ensures compliance, it often leads to inefficiencies, such as redundant testing or the prioritization of low-priority components within a system or piece of equipment. For example, in equipment validation, every function, whether critical to performance or not, may undergo testing, draining resources from areas that genuinely require attention.
A transition to applying critical thinking through a risk-based approach encourages teams to concentrate on functions that directly impact product quality, patient safety, and data integrity. This shift is at the heart of the move toward requirement-level risk assessment in both software and equipment validation.
Following this risk-based approach aligns with industry best practices and ensures compliance and efficiency.
When validation efforts are risk-driven, teams can concentrate their energy on the most critical functions—those that directly impact product quality and safety. Whether validating a software system or ensuring that equipment like centrifuges or filtration systems function correctly, requirement risk assessment ensures that the most vital aspects receive the necessary attention.
For example, in software validation, assessing the risk of specific functionalities (e.g., data integrity checks, audit trails) ensures that these high-impact features receive comprehensive testing. Similarly, in equipment validation, critical performance parameters (e.g., revolutions per minute of a centrifuge or the accuracy of a temperature sensor) will be prioritized, streamlining the process and reducing unnecessary testing.
Requirement risk assessment enables flexibility in how evidence is collected during validation. For high-risk requirements, organizations may demand extensive test documentation, including detailed logs, screenshots, and supporting attachments for each step. For moderate- or low-risk requirements, the validation may only require a final test summary report or coverage analysis.
This flexibility not only reduces the burden of excessive documentation but also ensures that teams do not overlook essential evidence when it is needed most. This balance of testing and documentation is key in ensuring compliance while improving efficiency.
The emphasis on risk-based thinking is echoed in many modern regulatory guidelines. The FDA Draft Guidance for CSA, for instance, shifts the focus from testing everything to concentrating on the most important aspects of a system or process. Similarly, ICH-Q9 and GAMP 5 highlight risk management as a critical component of a robust validation strategy.
By adopting requirement-level risk assessment, organizations are not only adhering to these guidelines but also enhancing their digital validation processes. A risk-driven approach ensures that both software and equipment are validated efficiently and effectively, reducing the possibility of regulatory scrutiny, and facilitating faster time to market.
When it comes to implementing requirement risk assessment, a digital validation software platform like ValGenesis VLMS is indispensable. With its Design Manager module, ValGenesis VLMS offers organizations the flexibility to apply risk-based approaches to validation, ensuring that both software and equipment are validated according to their risk levels.
Image 1: Requirements with individual risk assessment scores.
Here’s how ValGenesis VLMS supports this approach:
Image 2: Risk level determines required testing and documentation.
Adopting a requirement-level risk assessment approach goes beyond a mere shift in mindset; it represents a pragmatic method to enhance validation efficiency, ensure compliance, and uphold product quality. Whether you are validating software systems or physical equipment, this approach empowers you to direct your efforts where they are needed most, streamlining processes and reducing time to market.
With a digital validation platform like ValGenesis VLMS, organizations can fully realize the benefits of this approach, driving efficient, compliant, and effective validation processes.
To learn more about ValGenesis VLMS, watch the webinar "VLMS is the Best Technical Solution to Implement CSA Guidance."