Requirement-Level Risk Assessment: A Game-Changer in Validation

In the highly regulated world of life sciences, organizations must adhere to guidelines such as the FDA’s Draft Guidance for Computer Software Assurance (CSA), ICH-Q9, and GAMP 5.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.

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The Traditional Approach: Testing Everything vs. Testing What Matters Most?

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.

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Understanding Requirement Risk Assessment

Requirement risk assessment is the practice of evaluating the risk associated with individual requirements, whether for software functionality or equipment performance, and determining the appropriate level of validation effort. This approach allows organizations to:?

• Use critical thinking to determine risk levels: By assessing each requirement’s potential impact on product quality, user safety, or regulatory compliance, teams can categorize them as high, moderate, or low risk. This categorization drives the scope and depth of validation. ?
• Tailor testing strategies based on risk: For instance, high-risk requirements may necessitate rigorous testing and full documentation, including screenshots and attachments for every test step. On the other hand, low-risk requirements may only require basic test coverage, significantly reducing the validation burden without compromising quality. ?
• Optimize resource allocation: Rather than expending effort on every single requirement, teams can focus on critical functions, ensuring thorough testing and validation while minimizing time spent on less essential tasks.?

Following this risk-based approach aligns with industry best practices and ensures compliance and efficiency.

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The Benefits of Risk Assessment at the Requirement Level

Increased Focus on Critical Functions

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.

Flexibility in Validation Evidence

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.

Alignment with Modern Regulatory Guidelines

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.

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ValGenesis VLMS: A Digital Validation Platform that Enables Risk Assessment

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.

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Here’s how ValGenesis VLMS supports this approach:?

• Systematic risk scoring: The platform allows you to score the risk of each requirement based on predefined criteria such as impact on patient safety, product quality, and regulatory compliance. This scoring will systematically trigger required testing and documentation. Refer to image 1 above for a view of individual requirements with their associated risk scores.
• Customized testing based on risk: ValGenesis allows you to assign different testing processes depending on the risk level. For example, low-risk requirements may only require basic test coverage, while high-risk requirements initiate more rigorous testing protocols. The system’s flexibility ensures the appropriate level of validation effort based on real-world risks. Please see image 2 below for an illustration.
• Compliance with regulatory standards: ValGenesis VLMS aligns with industry regulations, allowing you to implement risk-based validation that complies with the latest regulatory standards. The platform helps ensure that your digital validation processes are efficient, compliant, and auditable.
• Centralized documentation and reporting: ValGenesis VLMS centralizes all validation activities, providing comprehensive documentation and reporting tools to ensure that every step of the validation process is recorded. This eliminates the need for manual documentation and guarantees an auditable trail for regulatory inspections.

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The Future of Validation: Risk-Driven and Digitally Enabled

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.?

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.