Software validation is a monumental task. But with the right tools, it can be a breeze.
Software verification tests examine how well a feature meets customer and business requirements. It’s not concerned with why the feature was built in a certain way but rather that it does what it should.
Detailed Reporting
The detailed reporting aspect of validation software ensures that all verification tests collected during the process are compiled and documented. This allows for a full breakdown of results so that all parties involved in the project can review the findings and identify any areas where improvement can be made.
Paperless validation testing aims to determine how well a proposed system meets a real-world need. It also encompasses a variety of tasks, such as user evaluation, usability testing, documentation creation, and more. The process begins with the planning stage, where the team establishes a clear set of requirements to work toward. This includes defining all verification tests that must be completed, setting up a schedule, and assigning resources to complete those tasks.
Once the verification test plan is finalized, the team performs these tests. This may involve conducting a code walkthrough to complete IQ, OQ, and PQ testing. This level of testing consists of a combination of technical and business-side personnel and can include things like stress testing or even operating the system under peak loads.
Software validation is less concerned with why a feature was built in a specific way and more focused on ensuring it works as intended. For example, a website that sells alcohol will likely have an age check. Still, the validation team is more interested in ensuring the software rejects underage users than in determining why the feature was designed to do so.
Automation
A validation system that automates the process is crucial. This is especially true if your software system needs to run long, end-to-end tests or for specific tasks such as user input. For example, a user may need to test for the ability to enter accurate data into an online form, or a QA engineer might need to verify that the search function is working correctly.
This type of automation can also improve the decomposition of lower-level requirements into higher-level ones, ensuring they are correctly mapped to components and subcomponents. This reduces the risk of errors, which could lead to costly rework later in the product development process.
It is also essential to ensure that the validation software solution you choose can automatically track all the test results, which is critical for any life science company. This makes the job of the Quality Assurance engineer much more accessible and saves time. In addition, the automation feature allows you to run tests when the server load is lowest (from 2 am to 5 am), which can significantly increase the efficiency of the tests.
The software industry is aware of the issues associated with validation testing and is making great strides to reduce the effort involved in validating software. As a result, life science companies should look for a validation support vendor that is pushing the boundaries to achieve faster and more FDA-accepted validations.
Scalability
Scalability is the ability of a software system to adapt to changing needs. In other words, it’s the ability to handle more users or data without crashing or slowing down. It’s an important feature to have when you’re growing your business. For example, if you get a massive spike in traffic or land that whale of a customer, you want to know if your infrastructure and tech stack can handle it.
While scalability is often seen as a technical problem, it’s a combination of two things: performance and process. Performance issues are easier to solve as they directly relate to the 1s and 0s that comprise a software system. Process issues, on the other hand, are more challenging to address.
To properly test scalability, you need to generate a realistic load of data that matches your original data. Then you can see how the system performs under these conditions and find ways to improve it. This can be done through horizontal or vertical scalability. Horizontal scalability involves splitting code into different parts that can be run in parallel on multiple machines, while vertical scalability adds more power to existing hardware.
It’s also essential to establish clear goals for scalability testing. This includes setting realistic targets for how much you can scale your system without crashing or bogging down. For example, it might be enough to scale a system by adding more servers, or you might need to upgrade your existing server hardware and software.
Integrations
Software integrations help to make the validation process seamless and more efficient. With the right integrations, data can be compiled and displayed in one place for easy reference. This eliminates the need to go between multiple systems when analyzing data and helps to reduce errors by creating a single source of truth. In addition, it saves computer storage space by having the information in a single location.
Several things need to be considered regarding medical device software validation. First, the system must be configurable to meet the user’s business needs. This configuration often requires proof as well.
Another critical aspect of software validation is testing and evaluating each component. This can include developing and executing a test plan, developing a requirements traceability matrix, and verifying that the software meets specifications. Finally, medical device manufacturers should focus their testing efforts on the areas that pose a high level of risk.
Lastly, medical device software developers should consider the implications of making changes to their software. This is because even a tiny change may hurt the overall system. This is why performing a regression test whenever software is updated is essential to ensure the new version doesn’t negatively impact existing features.
