HealthMarch 18, 2021

How Pharma Companies Test Their Critical Software: An Expert Q&A

On the hazardous worksite, operators work 24/7 to ensure continuous production and smooth operations of critical assets. The software that these teams use also needs to work without fail. 

I spoke with Duncan Cole, Project Manager at Wolters Kluwer Enablon, about his experiences in delivering complex Control of Work software to the most demanding clients, in the most critical industries. Duncan spent nearly 20 years in product manufacturing and operations before coming to Enablon. 

Out of all of Duncan’s past implementation projects, the process of delivering software to his pharmaceutical clients has proven to be the most rigorous. 

In what ways are your pharmaceutical clients different than your clients from other industries?

Duncan: In pharma there are many drivers to help achieve both safety and quality. A few batches of a certain product can be extremely expensive to produce and so it is imperative that we ensure every aspect of the production of these are met both from a quality and safety side - basically, quality and safety go hand-in-hand and there is very much an emphasis on that. 

The uniqueness of pharmaceuticals—versus other industries—is everything is linked to overarching regulatory standards and traceability requirements. If there is an issue, perhaps the FDA will come in to audit and investigate. They will look at every detail that could have impacted this, this can be down to the detail of the equipment used in the process, its maintenance history and any associated documentation associated with that, such as permitting. They may say, “You’ve used Enablon’s permit-to-work system, so the contamination could have occurred during the maintenance activities?” 

The people involved in this permit, what did they do? Who was trained? How were they trained? How was this product developed? Is there a loophole for why this mistake happened? 

Our pharma clients rely on our software to enable complete audit trails and traceability in their operations, day in and day out. 

Can you give an example of how your pharma clients test their software? 

Duncan: One of our pharmaceutical clients has a two-step approach to implementing software. Once UAT is passed, they give the software package to their quality team who then also do their own internal QC. 

Everything is documented to incorporate into global standards, basically a document/procedure about how the system works and how this is incorporated to the way of working for the operations and maintenance teams. 

So when we’re preparing a release for this client, we build in more time to ensure that everything that can get documented will get documented. 

Do you change your delivery approach for all of your pharmaceutical clients? 

Duncan: As a rule, when we release products to a client, we tend to get through UAT quite well. At Enablon, we are very rigorous with how we create packages and how we test and send these packages over. 

But for pharma clients, and all clients to be honest, we need to ensure that we match their software testing timelines and work with them every step of the way. 

We need to ensure that we do not impact upon any products that pharmaceuticals make, or indeed anything related to the creation of those products. Everything is linked. If we create a product, and we give it to our pharma clients, and then it causes a problem, then it potentially has an impact on the production of a lifesaving tablet. 

Product Manager - Wolters Kluwer Enablon
Tina Amirtha is Product Manager at Wolters Kluwer Enablon, with over a decade of product development experience in industry, spanning precision manufacturing, medical devices and aerospace, and now operational risk management at Enablon. Most recently, she was the product manager of Field Operations at Enablon, during which time the product expanded into the petrochemicals industry and continued its growth in oil and gas and pharmaceuticals.
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