Software validation is a critical process for businesses in highly regulated industries. It helps ensure that systems used in manufacturing, environmental monitoring, and maintaining 21 CFR Part 11 records work as intended and meet FDA requirements.
The validation process begins with a description of the software system, its installed environment, assumptions and limitations, testing and acceptance criteria, development procedures, and responsibilities for the validation team.
Defining the Requirements
For software validation in life sciences to be effective, it must clearly define the requirements. This is done through a documented requirements specification that accurately outlines the user’s needs and intended uses. This living document should be continually refined and updated throughout the software development life cycle.
This document is the master to which all other testing activities will be linked. It should include infrastructure requirements, the operating environment, the system and software specifications, and other factors affecting the software’s functionality. It should also include a risk assessment to determine the rigor required to validate the software and ensure it meets quality standards and regulatory compliance.
Ultimately, this document will be the basis for all future testing activity and help life science businesses establish consistency, transparency, and traceability across their validation efforts. The key to doing this is leveraging tools and processes that reduce the effort needed to perform and validate software while maintaining the integrity of the results.
Ideally, these tools and processes are embedded in a comprehensive quality framework like IQ/OQ/PQ (installation, operational, and performance qualification). This provides a step-by-step process to help ensure no critical aspects of the validation are overlooked. It is also important to implement robust change control procedures that manage any changes made to the software and that they are evaluated for impact on validation and adequately tested.
Developing a Test Plan
When developing a test plan, you must determine how to conduct the testing, what should be tested, and when. The test plan should also describe the resources necessary to perform the testing and how long it will take. The test plan is essential in the software validation process and helps keep the project on track.
A well-developed QA test plan should include a detailed description of the test scope, outline the testing methods, define testing tools, and have a timeline for completing the testing. Identifying any assumptions and risks associated with the testing is essential, which can be communicated to project stakeholders.
The QA test plan should also outline how defects will be managed and tracked throughout the testing cycle. This can include setting up a system to log and record the test results and providing opportunities for testers to report bugs via text logs, screenshots, or videos of software output.
Lastly, the QA test plan should define a naming convention for the tests. This naming convention can prevent team confusion when reviewing each test’s results. A good naming convention will also allow the team to quickly find a specific test, which can save time when executing them. It will also enable the team to easily compare and contrast the results of each test, identifying any discrepancies.
Performing Testing
Software validation is a vital step in ensuring software’s accuracy, reliability, and integrity. However, it can be complex and resource-intensive, especially for life sciences companies. This is why it is essential to prioritize validation support from your software vendors and take a proactive approach in evaluating the tools and processes they use to manage the lifecycle of their software products.
This includes identifying both production and testing environments’ hardware, software, and infrastructure specifications. In addition, it is necessary to establish what types of tests will be conducted. Some of the most common include functional automation, performance testing, and integration testing.
During this phase, conducting a skills audit is also helpful to ensure that your team has the required vocational competencies and industry experience. The goal should be to have a well-rounded team that can handle the rigor of the software validation process.
Ultimately, the quality of your software validation process will be directly related to how smoothly and rapidly you can bring new features to market. The key is developing a streamlined process that eliminates bottlenecks and enables you to leverage new technology quickly. This will increase your competitiveness while minimizing the risk of regulatory violations and other costly issues. The right tools can help you make this happen.
Documenting Results
A key aspect of software validation is documenting the results of testing. A validated system must be registered, and the testing strategy must be clearly explained. The documentation must include a description of the system, environment specifications, assumptions, limitations, testing criteria, testing schedule, and responsibilities.
The documentation must also identify test cases and provide traceability throughout the validation process. The test case identifies the inputs, actions, and events to be tested and the expected outputs to be verified. Testing every potential combination of input and output is impossible, but the testing should be sufficient to uncover a significant number of defects. A requirements matrix should also be used to help ensure the scope of the testing is commensurate with the risk determinations made for the software capabilities.
Ideally, the documentation should be online and easily accessible while complying with regulatory requirements. Records and information must be accurate and complete, as life sciences manufacturers often need to refer back to the original data points for additional analysis and business decisions. Additionally, the documentation must be enduring and readily available for future use. This is often accomplished by creating local and cloud-based backups with an audit trail showing the date and time of any changes to ensure the integrity of the data.
