Ensuring Safety and Compliance: 7 Best Practices for Testing Pharmaceutical Software 


Patient safety and regulatory compliance are top concerns for pharma firms. And just as drugs and medical devices undergo rigorous clinical testing, pharma software also undergoes testing to meet regulatory requirements and customer needs. 

This blog post will explore seven best practices for testing pharmaceutical software. You’ll learn how these practices can help you achieve the highest standards of safety and regulatory compliance. You’ll also discover how they help to foster trust with patients and regulators. 

  1. Run functional testing.  

Functional testing is crucial to ensure that pharma software functions according to specified requirements. It verifies the software and all its features work as expected.   

This testing method finds defects early in the development process. This prevents costly, time-consuming rework or, worse, the need to withdraw the software from the market later.   

When functional testing is not done correctly, defects may be missed. This can lead to software failures and safety concerns. 

  1. Put security testing in place.  

The pharma industry deals with sensitive patient and clinical data. It also faces the risk of cyber threats. Reliable security testing ensures that software is not vulnerable to data breaches, unauthorized access and other risks. These include data loss, which may lead to legal issues and a dented reputation.  

Security testing helps identify weaknesses in pharma software that attackers could exploit. It also creates a safety net by ensuring the software is secure and compliant with data protection standards and rules.   

By building security into the software development lifecycle, pharma companies can rest more easily when it comes to data protection. 

  1. Perform usability testing.  

Usability testing is the process of testing the software’s user interface. It identifies any issues that could impact user experience.   

Testing usability is crucial, as it ensures that pharma software is easy to use and navigate, especially for non-technical users.   

It can also help improve user adoption and satisfaction. This can lead to better patient outcomes. Improper testing can result in faulty software that may be difficult to use. This leads to user frustration, errors and patient safety issues.  

  1. Conduct performance testing.   

This type of testing gauges the software’s ability to handle specified workloads and operate under varying speeds.   

Carrying out extensive performance testing ensures that the pharma software performs at its best under different conditions, such as high traffic or data loads.   

Performance testing is essential because it helps identify bottlenecks or performance issues that may impair usage or hinder scalability.   

Not testing properly can result in slow response times, software crashes, or other performance issues that may end up impacting patient safety.  

  1. Validate compliance with regulatory requirements.   

Pharma software is subject to regulatory requirements that protect patients. These include industry-specific rules, guidelines and standards, such as those defined by the Food and Drug Administration (FDA) in the U.S.  

Validation testing applies to testing pharma software. It ensuring systems comply with these rules and standards. Once cleared, the software is deemed safe and effective, meeting all requirements.   

Failing to do this testing properly can lead to non-compliance. It may also result in legal issues, product recalls and damage to your pharma firm’s reputation.  

  1. Automate testing. 

Test automation speeds up testing, improves test coverage and reduces the risk of human error when testing software. Pharma software is often vast and complex. Test automation saves time and resources.   

But as with all testing, it’s vital that test automation is done right. If not, it may lead to defects or performance issues that, again, end up impacting patient safety.  

  1. Document and report test results.  

Documentation and reporting are necessary in testing. They help track progress, find patterns and make sure that all issues are addressed.   

It’s good practice while testing pharma software to record all tests and their results. This includes defects and flaws. This helps make sure that issues are addressed before the software is released.  

Robust documentation and reporting practices also contribute to compliance efforts. They ensure traceability and transparency. They show regulators that rules and guidelines have been followed. Plus, they support communication and teamwork among those involved in the development, testing, and regulatory review processes.  

Incorrect documentation and reporting can result in unresolved defects, leading to software failures, errors, or safety issues. You’ll also run into trouble with the regulators, as you’ll have no evidence of taking a risk-based approach to software testing

Summing up 

By following these seven best practices, pharma firms can enhance the safety, reliability, and compliance of their software systems. This protects patients’ well-being. What’s more, it strengthens trust with patients, healthcare professionals and regulators.  

With a proactive approach to testing and a commitment to adherence, pharma firms can navigate the complex landscape of pharma software with confidence and success. 

Testing for pharma & health care needs to be carried out by QA specialists trained for the industry. Choosing the right one can make a world of difference, so make sure you pick wisely.   


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