Case study

How using BioPhorum’s change notification best practices have helped create a clearer and more efficient dialogue with customers

The context

Change notification in the biopharmaceutical industry is crucial to operations, yet it was inefficient and did not help accelerate the adoption of single-use systems. Manufacturers often find that change-data packages lack technical detail and have short implementation timescales, and they may even learn of changes after the fact (or by chance). Meanwhile, suppliers can find it difficult to understand the impact of a change on a customer and manufacturers do not have a uniform set of needs and expectations. At the same time, the regulatory environment and how manufacturers use supplier data are unclear.
Watson Marlow

To help overcome these issues, BioPhorum and the Bio-Process Systems Alliance published An industry proposal for change notification practices for single-use biomanufacturing systems in 2020. This is a one-stop shop on change notification best practices for single-use biomanufacturing systems and provides new guidance on what information should be included in data packages. It also includes a decision tree to support change categorization.

Here, Sade Mokuolu, Strategy Implementation Lead, and Nicole Hunter, Global Regulatory and Validation Manager, at Watson-Marlow Fluid Technology Solutions (WMFTS), talk about using BioPhorum’s change notification best practices and how these have helped create a clearer and more efficient dialogue with customers.

The story

As part of our strategic commitment to provide end-to end fluid management solutions for customers, we knew we had to support our customers better when it came to notification of product changes. Additionally, there was a requirement to be involved in discussions to create alignment in the industry to ensure there was appropriate oversight provided to customers within this critical sector. There was no cohesive industry approach. We were also getting various timeframes to implement changes and there was rarely agreement on change severity. For example, one end-user would say, “This change is a major change and we want you to notify us in a 6- or 12-month period.” While for the same change, another end-user would say, “It’s a minor change and we only want a 3-month notice period.” Operating customer-to-customer like this is very inefficient and can lead to confusion.

The outcomes

With its best practice document, BioPhorum has brought to industry a much more uniform approach in many areas, such as requesting information from suppliers. This has been one of the key benefits for us after joining the group – using a uniform approach that the collective industry has developed.

We’re now getting a single message from our customers rather than having disparate messages about how they want to see information that, previously, could change from customer to customer. Requests used to depend on an individual customer’s internal policies, which meant we had a complex operating environment.

Now, we’re not guessing what the end-user wants. Instead, we have an industry-agreed document to demonstrate how these changes should look. As a result of the industry agreed guidance and our continuous improvement approach, we have compiled the detailed supporting information in a stream-lined way to implement a change. Therefore, customers are more likely to accept these changes without the need for additional explanation. Mike Tucker, Global Quality Manager at WMFTS summed up the positive impact the change has had for the organization.

Since implementing the BioPhorum Change Notification approach, we've seen a much faster customer acceptance rate, saving time and effort for us and for our customers

Mike Tucker, Global Quality Manager at WMFTS

The benefits

Because of BioPhorum, we now have a much more collaborative and centralized approach when end-users approach suppliers for information and overall industry engagement. It’s like the 80/20 rule. Generally, 20% of customers have unique requirements but at least 80% of requests are the same. BioPhorum has given us a common format and approach for responding to our customers. This uniform way, where end-users and suppliers have agreed on the severity and timeframes of changes, is a huge step forward and has brought efficiencies to our company compared to where we were before. It’s also less complicated, and has a clarity of approach and expectations.

Lessons learned

One of the challenges when bringing in this type of change notification policy is that our customer base is quite diverse, with biopharm making up around 55% of our business. Our challenge is how to get our colleagues to view changes in a similar way across biopharm and non-biopharm sectors, who don’t necessarily need the same level of change notification. Communication and getting buy-in to this process change can also be tough. Our advice is to think carefully about how to have those conversations, especially when organizations have different sites with different process attributes. Communication and collaboration are the two keywords that help to embed the processes. Also, these changes will take time. We’re still going through the process of managing change notifications within our organization, so it’s not something that is ever finished – it’s a continual process of improvement. But BioPhorum has given us a template to do this in a more effective, stream-lined way.