When adopting computer software in controlled settings, regulated organizations face some of the most time- and resource-intensive tasks. The following steps can reduce the pain of this process and ensure the highest levels of compliance.

Define Your Requirements

In a highly regulated environment, validating computer software can take time and effort. It is true in the case of pharma manufacturing, medical devices, aerospace, and other industries that must adhere to strict FDA regulations. Defining the requirements for a validation software solution is an important first step. This process helps reduce errors and ensures the software meets its intended purpose. Having clear and accurate conditions also allows developers to build better products that fit user needs. Requirements should be documented in a document called a User Requirements Specification or URS and validated to ensure that they accurately reflect the will and goals of stakeholders. O can be done through a process known as internal software validation or by performing external software validation. Internal software validation checks that the URS is precise and comprehensive, while external software validation is a higher-level assessment that checks that the product satisfies its intended use. It is less concerned about why a feature was built in a certain way and more interested in whether it works correctly.

Create a Test Plan

The next step in a good software validation process is to create a test plan. This document outlines the project’s goals, scope, approach, risks, resources, and schedule. It also identifies the team members, tasks, and milestones. The best test plans are concise and organized, avoiding technical language as much as possible. They also identify the expected outputs of the testing process – what you want from it. It includes things like scalability tests, performance tests, and security tests. It is also the point where you should specify any hardware, software, or operating system requirements for the tests. Be sure to include OS editions and versions (not just the names) and any other unique factors to consider when executing the tests. Finally, the test plan should include a list of all the work products that will be tested. It is important that the tests don’t go over budget or time and can still be completed on time. Also, it allows the QAs to estimate better how long each task should take.

Create Test Cases

Once you understand your requirements well, it’s time to create your test cases. These will help you determine which software features and functionality must be tested and how often they should be retested. Your test cases should be clear and easy to read, using simple language and consistent naming conventions. They should also include the test steps, expected results, and any preconditions/assumptions for the tester to understand. Depending on the scope of your project, you may need to create several test cases to cover all of your functionality. However, if your software is used for highly regulated processes such as pharmaceuticals or medical devices, it’s important to focus on the most critical functionality first. Regulatory bodies like the FDA expect you to have a documented plan for when and how you will conduct retests of your computer software. You should follow a risk-based approach, with the most important functions being tested more frequently. It will ensure a more efficient process and reduce validation costs while maintaining high-quality standards.

Conduct Tests

In regulated pharmaceutical and medical device industries, FDA software validation is crucial. There’s no room for error when human lives are on the line, and strict regulations mandate that companies follow a strict quality system to minimize risk and ensure that production is done right. A detailed outline of verification and validation testing must be established. The verification and validation process thoroughly inspects all aspects of the software system to confirm that it complies with requirements, design specifications, and standards. This phase includes code reviews, walkthroughs, inspections, and specification analysis.

Regulatory bodies offer specific guidance for using commercial off-the-shelf (COTS) software in their quality systems, so these guidelines must be followed closely during the validation process. It’s also a good idea to work with a software and validation vendor who has experience working with COTS software. The validation process is the most time-consuming and resource-intensive part of installing new computer software in a regulated environment. But with careful planning and a good partner, you can streamline the process and reduce risk.

Document Your Results

To prove that a software system will fulfill its intended purpose, you need to validate how it will be used. It is accomplished by following the IQ/OQ/PQ framework and creating a varied group of test cases that cover common scenarios that will be utilized in the system. Conducting these tests and documenting them as you go is where the validation process kicks in. Your documentation must include your testing plan, the established tests that you’ll use to demonstrate compliance, the final report, and your software-use procedures. Leveraging your vendor’s work to perform comprehensive testing and documentation will save you much time. This approach is especially effective when validating commercial software or an existing system modified to meet your company’s specific needs. Michael Martone has over a decade of experience guiding organizations on Quality, Compliance, and Validation. He currently leads the development of standardized, automated, and scalable testing suites and solutions at MasterControl, including the patented Validation on Demand product. He is also a key member of the Product Management team overseeing the company’s validation offerings and solutions.

By Sambit