The road to standardization How Bilthoven Biologicals used the modernizing of their IT infrastructure to transform their labeling process after standardization
- Risk of noncompliance
- Manual data entry
- Manual quality control
- Unplanned downtime
- Lack of integration to ERP system
- Many disconnected labeling systems
- Heavy support burden
- Single centralized solution
- Document management system for labeling
- Integration system (for SAP)
- Increased efficiency
- Cost reduction
- Less unplanned downtime
- Template reduction
- Simplified IT support
- Centralized label purchasing
- Shift to Just In Time Inventory system
Standardize your labeling to ease IT support,
reduce material costs and ensure
Bilthoven Biologicals BV (BBio) is a pharmaceutical company based in the Netherlands. It is their ambition to protect the world’s infant population with affordable vaccines. As a part of an overall project to modernize their IT infrastructure, BBio seized the opportunity to implement a label management system and standardize their label production process.
BBio is in the process of modernizing and standardizing their IT infrastructure. They were implementing a new SAP system, and they were looking for a label management system that could integrate label printing with their master data. BBio’s label production process involves printing paper labels for WIP, product ID, box, pallet and shipping. They also print synthetic labels for samples that are stored in fridges etc. They use about 25 printers from two manufacturers, and the label printing is largely handled from one facility in the Netherlands.
Fragmented labeling landscape impacts productivity
As is often the case with pharmaceutical manufacturers, BBio had a wide variety of solutions for printing labels from different vendors, as well as custom-made Visual Basic solutions. The large number of disparate, disconnected systems placed a significant burden on the IT department, who struggled to support so many systems. The lack of support was a potential high risk for unplanned downtime, which in turn could have a costly impact on production.
Paper-based processes increase errors
Label maintenance was also a challenge. Since BBio had no integration with their master data, maintaining labels was largely a manual process, which required a quality inspection person to check the labels that were produced. The lack of an automated quality management system made it difficult for the company to comply with regulatory requirements for all of their labels. Paper-based processes increased the likelihood of user error and meant that implementing label change requests and performing quality assurance activities required a great deal of time and resources.
De-centralized production leads to lack of consistency
“We were in a situation where we no longer had an overview of all of the templates and label systems we were using“, relates Martijn Huijbreghs, IT Application Manager with BBio. “Label design and production were spread out over a number of employees, so we lacked consistency in our label templates. In order for us to comply with regulatory requirements and to improve operational efficiency, we knew we needed a standardized labeling solution.”
In order for us to comply with regulatory requirements and to improve operational efficiency, we knew we needed a standardized labeling solution.
The right product for a highly-regulated company
BBio was familiar with NiceLabel, as they had used a version of its labeling software for printing labels from their Laboratory Information Management System (LIMS). “When it comes to label software, there aren’t many vendors that offer a complete package that suits the needs of a highly regulated company like BBio. After we researched what was available on the market, we saw that NiceLabel’s software had evolved into a mature label management system that fit snugly into the controlled environment of a highly regulated company, states Huijbreghs.
BBio implemented NiceLabel to centralize and standardize their label production. They use NiceLabel’s Document Management System (DMS) to control and track their labeling. As opposed to having several people responsible for designing labels, BBio now has one employee responsible for label design, thus simplifying their operations. They now have complete integration with the master data in their SAP system, and they have also integrated with their MES, Pharmasuite, to print WIP and product ID labels. Integrating NiceLabel with their SAP system also gave them a unique opportunity to validate all of their GMP master data.
Standardization reduces cost and increases efficiency
Implementing a standardized label management system has made life easier for BBio’s IT department. Instead of struggling to support a wide number of different systems, the IT department only has to focus on one system. This means less unplanned downtime, as the IT department can quickly respond to any issues and readily address them. By centralizing label design with one employee, BBio enjoys improved label consistency. Now that label production is integrated with the MES and ERP systems’ master data, quality assurance tasks are easier to perform, thus reducing the labor costs associated with using a quality person to check each shipment. BBio can meet regulatory requirements and they have control over their label production process.
After we researched what was available on the market, we saw that NiceLabel’s software had evolved into a mature label management system that fit snugly into the controlled environment of a highly regulated company.
Efficiency gains extend beyond label printing
Now that BBio had a consistent label production process, and as a result, had significantly decreased the number of label variations needed, they were able to centralize label and label hardware purchasing. Prior to implementing NiceLabel, BBio had to purchase large amounts of blank media in a variety of sizes in order to support the vast number of label variants. They were forced to keep a large inventory of labels on hand, as they couldn’t risk running out of a particular label and dealing with the unplanned production downtime that would result. Yet the greater the inventory, the larger the amount of cash tied up in that inventory, cash that could be used in other areas. After centralizing label purchasing, BBio has been able to reduce the variations of labels needed, the amount of label stock required and the number of suppliers used. By moving from keeping a large inventory to a Just In Time inventory system, they are able to free up cash reserves and operate in a more agile manner.
Standardization transforms procurement
According to Huijbreghs, this level of standardization has had a positive business impact. “The gain in template management is in itself a win. Having fewer templates and one designer guarantees less maintenance and a uniform label design. But we gain even more by being able to standardize our label materials and even our printer hardware. This guarantees easy IT support, reduces material costs and ensures less downtime because you have everything in stock.” By implementing NiceLabel, BBio has not only transformed their label printing, but their sourcing and procurement processes as well. The center of excellence approach to label procurement and production ensures a consistent and efficient label production process.
The right long-term solution
Next steps for BBio include implementing a Test and Production environment, which will enable them to preview label changes before they are deployed into a live environment. They are also going to extend their labeling system from manufacturing to QC Labs using NiceLabel’s web printing functionality. BBio believes that NiceLabel gives them the platform they need, not only to address their current challenges, but also to be prepared for future growth. “The NiceLabel platform is a turnkey label management solution for Life Sciences“, comments Huijbreghs. “It is the ideal long-term solution for our needs.”
Bilthoven Biologicals Case Study
How Bilthoven Biologicals used the modernizing of their IT infrastructure to transform their labeling process.