10 Effective Test Management Techniques for Pharma Software

The pharmaceutical industry operates under strict regulations. Firms are subject to various standards and laws that protect patient lives. This includes good manufacturing practices (GMP) and good clinical practices (GCP), as well as strict data privacy laws.

For pharma firms, their software – including their backend systems – must match up to their physical offerings and follow the best quality and safety standards. In clinical trials, patient data management, or manufacturing processes management, the software must adhere to certain compliance standards. It must also provide accurate and reliable results, minimizing risks.

Here’s where test management techniques come in.

What is test management?

Test management is a complete process. It ensures the quality and reliability of your pharma software by systematically managing the entire testing lifecycle from test planning to continuous improvement. Key aspects of test management involve a safe and effective test plan followed by controlling and monitoring all the activities about testing your software.

Test management in software testing is crucial for delivering top-level software that meets and exceeds user expectations.

Here are 10 test management techniques to help you make your pharma software better:

Requirement traceability

Traceability is a key test management concern. It ensures that every test case is linked to a specific requirement or user story.

Traceability also ensures that all requirements are covered by tests. It works because it lowers the risk of gaps in testing.

Maintaining clear traceability helps you verify that critical functionalities, such as data handling and user access controls, have been tested and that they comply with regulatory standards.

Risk-based testing

When testing it’s worth remembering that not all aspects of your pharma software carry the same level of risk.

Risk-based testing is a method that focuses testing efforts on areas that show elevated levels of risk. This might include modules that handle sensitive data or control manufacturing processes.

Focusing on these high-risk areas means your testing efforts are well-optimized. It also helps to ensure the most critical parts of your software are thoroughly tested.

The benefit of risk-based testing is that you use resources more efficiently and address the issues that matter most.

Automated regression testing

Pharma software is subject to frequent updates. This can be due to regulatory changes or system enhancements. Automated regression testing helps ensure the latest changes don’t affect existing functionalities.

This test management technique is useful in environments where continuous testing is needed. It provides faster feedback on the stability of the system and faster validation of changes.

Test data management

Pharma software generates and handles vast amounts of data. Imagine this sensitive data falling into the wrong hands or being managed incorrectly. So, security of data is of utmost importance.

Effective management of test data is crucial in pharma software testing. This process involves creating, maintaining and securing the data used in testing. Proper TDM ensures that the data accurately reflects real-world scenarios and is anonymized to protect patient privacy. It also helps make the data readily available whenever needed – ensuring smooth and efficient testing.

Validation and verification processes

The best way to ensure your pharma software complies with regulations is validation and verification. Here’s why each is so important:

Validation: This process ensures your pharma software meets the needs and expectations of end-users.

Verification: This checks your pharmaceutical software is built correctly in line with the required specifications.

Both these processes are essential in pharma software testing, as they provide a guarantee that the system is both compliant with regulations and fully functional.

Continuous integration and continuous testing

A fast-paced environment like pharma requires continuous integration (CI) and continuous testing (CT).

CI involves frequently integrating code changes into your pharma software.

CT ensures that your software is continuously tested at each stage of the development process.

This approach allows for swifter detection of defects, which improves the overall quality of the software.

Cross-functional collaboration

Effective test management in any software testing requires collaboration between various teams, including:

Developers

Testers

Regulatory experts

Business analysts

The goal of cross-functional collaboration is to ensure everyone is on the same page regarding testing goals, and fully understands the specific regulatory requirements. By working together, teams find potential issues quicker and can fix them as soon as possible. This leaves less room for errors.

Compliance-driven testing

At the risk of sounding like a broken record, the pharma industry is bound by stringent regulations, making compliance-driven testing an essential TM technique. This approach focuses on ensuring that your software meets all regulatory requirements. It involves creating test cases based on standards, such as FDA guidelines and GDPR rules. By doing so, you ensure the software follows all the necessary regulations. This slashes the risk of warning notices (a serious concern) and non-compliance penalties (your worst nightmare!).

Defect management

In pharma software, errors come at a high cost, so effective defect management is important. Defect management lets you track, prioritize, and resolve those defects in a systematic manner. In a robust defect management process, critical issues are triaged and resolved as soon as possible. This minimizes the risk of defects having an impact or effect on the final product, resulting in better-quality software.

User acceptance testing

UAT is a critical test management technique performed towards the end of the software testing lifecycle.

During UAT actual end-users test your pharma software. They verify that it meets their needs and works as intended in real-world scenarios.

Because pharma systems can be complex, getting real users to test the software before launch helps identify any issues you may have missed during earlier testing phases. So, UAT is a final check to ensure your software meets user needs and is ready for production.

Conclusion

Effective test management in pharma software is not just about identifying or fixing bugs and defects. It’s about ensuring the software is:

Safe

Compliant

Fulfills its intended purpose

Implementing the test management techniques listed above will help you enhance the quality and reliability of your pharma software, helping you create better patient outcomes.

Whether you’re dealing with clinical trial management systems, electronic health records, or manufacturing software, apply these test management techniques in your software testing. They’ll help you achieve the highest standards of quality and compliance.