Understanding the Role of Validation Software in Regulatory Compliance

Role of Validation Software in Regulatory Compliance

If your company is involved in regulated activities, you need to validate the computer systems used to create controlled products or perform relevant business procedures. This includes off-the-shelf software, configured applications, and software-as-a-service (SaaS) solutions.

Many companies worry that validation is a lengthy and time-consuming process. However, it does not have to be.

Requirements Analysis

Software validation is confirming that a piece of software meets its stated requirements. It’s typically a manual process involving inspections, reviews, and developer walkthroughs. It also includes verification testing. Verification tests compare the intentions and requirements specified in a User Requirements Specification (URS) document with how the software works.

For example, suppose you build an e-commerce website with an “Add to Cart” button. In that case, it’s essential that the software displays and functions correctly on all different browsers, devices, and operating systems. This is known as cross-browser testing and would be a part of the validation process. You must only test the features of your system that you will utilize in production, inventory, or quality control. This helps to reduce your validation time and cost.

Whether you’re using software that is part of your device or an external software tool, all companies subject to FDA regulations must validate their software. Even if you purchase the software from a third party, you must describe how you will validate it and then show proof you have. You must follow the guidelines in the FDA’s General Principles of Software Validation guidance document. However, how you apply these principles to your unique situation will vary widely.

Test Planning

Software validation, like some pharmaceutical validations, involves verifying that a configured system meets user and business requirements. This includes ensuring that any documentation associated with the software is precise and accurate, including instructions on installation and configuration, usability guidelines, user support information, and more.

The first step in this process is establishing the specific requirements that your company needs to meet. This involves creating a test plan and a roadmap for the testing process. It describes the project’s scope, defines the approach and risks, and documents your strategy to ensure your product satisfies all specified requirements.

In addition to defining the exact requirements of your software, this stage also requires that you select a team that can work together to implement these tests. Your team members should have the right experience to tackle your specific challenges, and they should be able to work efficiently under pressure.

Finally, defining your testing process as a test plan is essential. Fortunately, there are many tools available that can help you create an effective test plan. These include testing frameworks, automated testers, and other validation tools. These tools can help you save time and money while reducing the risk of failure. An excellent place to start when developing a test plan is the StrongQA website, which has a template for creating one.

Test Execution

Test execution is a process that tests the application’s features to see if they function correctly. It requires a detailed test scenario with definite steps, data, and expected results. It also includes a requirements traceability matrix that connects each test to its related requirement.

Testing is done in different stages to check for different types of errors. For example, verification testing checks whether an application carries out the plans in its design and specification documents. This type of testing also confirms that the software meets stakeholders’ expectations.

On the other hand, validation testing goes one step further to verify that the software satisfies its intended purpose (high-level checking). It also confirms that the software meets the needs of stakeholders, not just as the specifications artifacts but as the actual needs and goals of the users.

Validation testing is often done by experienced Quality Assurance engineers who go through every aspect of the system to check for errors and ensure each feature works. This type of testing is performed using real devices, browsers, and operating systems. This way, it is more accurate and can prevent software errors that would be difficult to reproduce on a simulator. It also helps to identify bugs that were not found during the verification process and catch those errors at an early stage.


Computer system validation (CSV) can be one of regulated life science companies’ most resource-intensive and time-consuming compliance activities. It’s also an essential way to mitigate industrial and cybersecurity risks. But despite the complexities involved, it’s pretty simple when broken down into clear steps.

Software validation ensures that a particular piece of software meets user needs and the project team’s stated requirements. This high-level checking is accomplished by examining the software to confirm that it meets all specifications and is suitable for intended uses. It’s important to note that this step differs from verification, which focuses more on the technical implementation of features and if they’re built as planned.

During this phase, validation professionals must create test cases that can identify all inputs and outputs of the software. This helps to minimize the cost of testing by identifying a minimal number of tests that can be used for each feature. During this phase, developing a requirements traceability matrix is also helpful in ensuring all test cases can be tied back to the original functional requirements.

Consistent quality is the most critical factor in preserving reputation and competitiveness in a world where medical device recalls are depressingly familiar. The best way to do this is by using validated and reliable software systems to vet business partners, map supply chains, monitor assembly lines, track metrics for perishable products, and more.

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About the Author: Katherine

Katherine is a passionate digital nomad with a major in English language and literature, a word connoisseur who loves writing about raging technologies, digital marketing, and career conundrums.

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