Testing pharmaceutical software: when domain knowledge is the key

“Is domain knowledge required for software testers?” was the question once we bumped into on Quora and the one that was right to the point. At that moment one of our QA teams was assuring the quality of the large software product from the pharmaceutical industry. It proved to be experienced, to excel in we needed not only comprehensive technical skills but also very strong domain knowledge.

From our experience, we’d like to share some tips with QA engineers who can also get involved in testing pharma and want to excel. In short, this article will be your first step and a guide on your pharmaceutical knowledge quest.

To those who are new to pharmaceutical industry: 4 basics you should know before stepping into testing

While this knowledge may be irrelevant for testers directly, it helps perceive the spirit of the industry.

1. Pharmaceutical companies develop, produce, and ship drugs for medication.
2. The main business objects of pharma companies are brand medications, medical devices or generic drugs. (Generics – drugs that are equal to brand-name products by nature and the difference between the two is not medically significant).
3. Pharma companies are subject to numerous laws and regulations regarding patenting, testing and ensuring safety and efficacy.
4. Pharmaceutical market growth is driven by emerging markets such as China, Brazil, India.

As for our case, the customer realized the importance of both high-quality assurance and knowledge transfer. With this in mind, he conducted constant knowledge sessions to teach us, testers, the business context of the product development and the basics of the industry in general.

Before testing, you should also be aware of the main issues facing the industry. Taking them into account, you will show your competence to the customer and share his main concerns.

1. The time to get a product to market is taking longer, thus shortening the patent exclusivity period.
2. Companies are struggling with the drugs pipeline.
3. Major companies are facing generic competition.
4. Cutting costs (headcount reduction, introducing lean techniques) is the key topic across the industry.

8 tips for testing pharmaceutical software

Tip #1

Test accuracy and relevance of the data and numbers entered into the system. A slight change in numbers may result in significant changes and defects. Since the pharma software deals with medicine, incorrect data can have very serious consequences (wrong dosage, for example).

So, you have to pay a lot of attention to data verification. Pay attention to the following: for American customers – the dates need to be American format, and of course for European customers – European format. For example, 3.5.2017 in France will be read as the third of May, 2017. In the USA – the fifth of March, 2017.

Tip #2

Don’t forget to learn the requirements of the environment, regions, and languages the software should be tested against. Keep in mind that there are different operating systems locales in different regions and communication protocols may function with errors.

Tip#3

Usability testing is very important. It’s vital to identify the type of personas who will use the system and test it according to their usage scenarios. Nurses, physicians, patients expect different functions from the system. Any inconvenience in these scenarios is critical. Think from the users’ perspective to find all the bugs.

Tip#4

Take into account FDA guidelines. Food and Drug Administration provides guidelines for mobile and web healthcare applications for medical devices. For example, there are strict criteria for functional tests passing or failing.

Tip#5

Naming matters. You will most probably come across different medicine known under different names or differing in one letter only. Make sure they are all spelled correctly, as this can also result in very severe consequences. We checked all the names on the EphRMA website. Ask your customer about the reliable source of such information.

To be on the safe side, check the list of medications with those legally permitted in the target countries.

Tip #6

Devices play a big role in pharmacy management systems. For example, bar code scanners. Their usage has to be tested because medicine can’t be delivered to patients without them.

Tip #7

In case you’ll have to work with emulators, check the emulators first to make sure that the defects you’ll come across have arisen due to poor integration.

Tip #8

Pharmacy systems always communicate with other systems, e.g. payment systems, insurance systems, and welfare systems. These systems will confirm or reject the transaction, so communication has to be consistent and reliable. In short, integration and thorough performance testing is a must.

So these are the basics of the pharma domain and our tips to perform comprehensive pharma software testing.

Have you ever verified the quality of healthcare or pharma apps? Don’t hesitate to drop us a comment!