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Q&A:
bioMérieux’s Journey to Electronic
Batch Records (EBR)
BioMérieux designs, produces, and commercialises innovative in vitro diagnostic solutions that improve patient outcomes and protect consumers. The company’s three main areas of focus are molecular biology, microbiology, and immunoassays. They produce over 100 million products each year.
MasterControl spoke with bioMérieux Business Process Owner Sebastian Roussel about how the company is improving manufacturing through adopting an electronic batch record (EBR) solution.
1.
What were some of the challenges you faced when managing your batch records that made you realise you needed to switch to a digital solution?
We used paper for batch records, which made it difficult to access and use data. Really, it was very time-consuming or impossible to do that. Paper also presents data integrity issues because we have no link to our equipment, so we have to copy the data. This involves checking all the information to be sure we completed the process correctly. Today, we use the EBR functionality in MasterControl Manufacturing Excellence (Mx) which makes it easy for us to enter data and track all the information and actions completed in the system. All the information we need from our equipment is automatically logged in real time, meaning there are no data integrity issues, and we save time for the review of our batch records. That’s flexibility we didn’t have before.
2.
As one of the stakeholders involved with the purchasing decision, what made you choose MasterControl’s EBR over other solutions?
We looked at numerous market solutions before choosing MasterControl. There were two criteria that made us choose MasterControl. The Mx module is a market standard solution which complies with our quality rules and regulations. It’s very important that the solution is able to continually evolve because the industry’s always changing and we have to stay up to date. The changes in the product have a limited impact on our validation workload because we use the tests carried out by MasterControl. The second criteria was that it’s a no-code solution. Operators and technicians don’t necessarily have coding skills or a background in digital tools, so the no-code solution was very important.
3.
How does our EBR compare to tools you’ve used in the past?
It’s an easy-to-use tool for end users and administrators. As a SaaS solution it integrates easily into information systems, such as our enterprise resource planning (ERP) system. Some of our facilities also use other solutions, in particular an MES that is more cumbersome to set up in terms of qualification/validation and integration into our IT infrastructure, and which requires updates and version changes that take up a lot of our time.
4.
How was your implementation experience?
To start with, we had a pilot site and we implemented MasterControl on two different activities. We have a lot of different processes, but we just focused on those two and created an interface between MasterControl and the ERP. The implementation took six months from the start of the project to go-live. We have 60 people who were trained on and use the system daily for the pilot site. Now, more than 150 people use the solution in four manufacturing sites and in the coming year we expect the last two manufacturing sites in Europe will implement and use MasterControl.
5.
Based on your experience, what advice would you give to another prospect before they go ahead with implementing Mx?
We initially thought our processes were very specific and so we assumed we would have to change our processes to match a solution like MasterControl. This was not the case. The MasterControl team worked with us to build a roadmap to help us use the solution and integrate it into our processes. Another important point is the support you receive after go-live. Digital solution support and training in the field is key and we’ve optimised our template after feedback from the field.
6.
How have you been measuring the success of Mx? Are there certain metrics you’re tracking?
It’s difficult to measure or evaluate the return on investment for a digital solution. We’re looking at a number of different criteria. One of the most important things is user acceptance and feedback. We’ve had some extremely positive feedback, which reinforces that we made the right choice. With the EBR, we eliminate user tasks such as physical signatures and calculations, which are automatic. We also carry out a review by exception, where we check only the specific points we want or those that fall outside the established rules. We can integrate monitoring or alert parameters to ensure that our processes always meet the required conditions. We have access to all data, which enables us to react quickly in the event of a search or investigation, and to set up dashboards. We improved our performance and quality with a digital solution.
7.
You mentioned integrations earlier. Can you tell us more about your integrations and the benefits you’ve seen from that?
The integration is managed by MasterControl, which makes it easy for our IS team to manage their workload. And with the integration we can use single sign-on, which makes it easy.
8.
What does quality mean to you and how does it affect bioMérieux?
BioMérieux is an in vitro diagnostics company so we sell medical devices which can have an impact on the life of one customer, one patient. So the quality of our products is of utmost importance.
9.
What does the future look like for bioMérieux and Mx?
The goal is for all the manufacturing sites in Europe to use Manufacturing Excellence. We’ve been planning for that, and I think at the end of 2025 we will have all the European reagent manufacturing activities covered by the solution. Today we’re at the beginning of our partnership with MasterControl and we plan to use the solution to cover all our manufacturing needs. We’re very happy with this solution today, and the feedback from the field and the users is very positive, which for us is the most important thing.
How MasterControl Resolves Critical Issues for bioMérieux
MasterControl Manufacturing Excellence (Mx) provides electronic batch records (EBRs) which completely remove paper from the manufacturing floor and give users the flexibility they need to quickly adapt and have EBRs on every line.
Benefits of MasterControl Manufacturing Excellence
Reduce Production Errors:
EBRs eliminate errors that come from handwriting and greatly reduce those from data entry. Using calculations within the solution also eliminates mistakes from calculations, gives you more control over data format, and flags operators if they attempt to input data outside of preconfigured limits.
Rather than reading through the entire batch record before releasing a batch, review by exception lets users immediately see areas that require review. This reduces time to release from days to hours or minutes.
Data Integrity:
When production data is captured on paper, it stays on paper. The only way to get insight from that data is to manually input it into a digital tool. With EBRs, that data is automatically captured and can be analysed within the solution.
In-Line Training:
When operators perform tasks that they’re not trained on, the company may wind up scrapping the whole batch. Connecting EBRs to training records tells you when an operator needs training and lets the employee immediately complete the training.