How to Secure GxP Compliance in Pharma with Test Automation

Maria Homann

Automation Expert

Testing plays a key role in ensuring GxP-compliance, but it can be difficult to test to a satisfactory degree due to time and resource constraints. Test automation can be implemented to aid this, but complex automation frameworks tend to take away additional resources. Learn how to overcome these barriers with the right testing approach.

This article is written in collaboration with Pharma IT.

GxP is an abbreviation of Good Practice, with an ‘x’ in the middle, representing various fields, such manufacturing (GMP), laboratories (GLP), and distribution (GDP).

GxP is a set of guidelines put in place to ensure that products are safe, perform as intended, and are compliant with the standards set in the field. This goes for a range of products - from drugs and medical devices to food and cosmetics. All of these must adhere to GxP in order to be put on the market for consumers to use.

In short, GxP is the quality stamp in pharmaceuticals. And it’s up to every manufacturer to ensure that they meet these requirements - which is not a simple task.

Test automation can be strategically implemented to speed up quality assurance processes. The success of this endeavour does, however, depend on the approach taken.

In this article, we’ll share how automation of User Interface (UI) testing can free up resources dedicated to User Acceptance and PQ Tests so that testers can focus on what really matters: processes, people, and overall functionality.

This approach will enable the dedication of more time and resources to more complex tests, more thinking, and faster documentation, rather than repetitive, manual tests.
Consider the following case, where test automation was successfully implemented.

Case example: Major pharmaceutical company automated tests for 95% UAT automation coverage

A pharmaceutical company faced the challenge of keeping up with critical product testing in connection with platform upgrades.

At each upgrade, domain experts had to perform rigorous User Acceptance Testing (UAT), which required many hours of manual testing. The process was not only laborious, but also at risk of human error, due to the large amount of manual data migration.

The tests were performed by domain experts without programming experience, which meant that, to automate, they had to find a no-code solution.

With Leapwork, a no-code test automation platform, in place, the testers were able to automate 95% of their tests for a high coverage supplemented by 5% manual testing, and they were able to run checks at every system upgrade.

As a result, countless hours were saved per upgrade - hours that could instead be spent on exploratory testing, product development and innovation.

Why test automation helps ensure GxP compliance

As with all quality assurance, testing is key.

In general, the more you test, the more confident you can be in the quality of the product. More testing includes increasing coverage and frequency of testing to ensure that you not only run a wider range of tests, but that you run these tests every time a change is made that could impact the results of that test.

In software testing, it can pay off to automate those tests, because automation allows you to test at higher speed and with high accuracy, allowing you to eliminate manual, repetitive tasks with risk of human error.

By introducing test automation and removing the tedious, repetitive parts of testing, time can be freed up for other, more value-generating tasks.

In pharmaceuticals, however, test automation often presents a challenge: It requires programming skills to use, when the test automation tool is code-based. But the people who are closest to the test or process are typically not programmers. Often, they have a background in medicine or life science, not in computing.

How to automate tests without code

In order to enable automation of, for example, UATs it is essential that tests can be managed by anyone - regardless of programming experience.

The optimal test automation tool gives an easy overview of the test or process and resembles the user journey in the closest way possible. This means the test looks very similar to how the tester would describe the process. It’s probably safe to say that that isn’t lines of code, but rather something like a flowchart.


test automation flow example


Leapwork and Pharma IT: A no-code solution for GxP compliance

Leapwork’s no-code test automation platform allows domain experts to set up, execute, and maintain automated tests without writing a single line of code.

By freeing up time on testing, the quality assurance process and GxP compliance efforts can be sped up without compromising safety and security.

To this end, Pharma IT offers a fully GxP-validated and Cloud-based test automation solution aimed at small and medium-sized Pharma and Biotech companies. This enables customers to get started with test automation quickly, while also gaining the advantages of the Cloud: Scalability, security, speed, and ease-of-use.

Learn more about no-code test automation

Learn more about no-code test automation in our whitepaper: Test Automation: The No-code Way.

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