Global Biotechnology Company Centrally Manages Labels with TEKLYNX

A Global Biotechnology Company Transitioned from Disparate Labeling Systems to Centrally Managing Labels for 15,000 Products with a Single Solution

TOPICS: ENTERPRISE LABEL MANAGEMENT, REGULATORY COMPLIANCE, MEDICAL DEVICE

bioMérieux is a multinational biotechnology company that was founded in 1963 and is driven to improve public health around the world. bioMérieux serves customers in more than 160 countries with the support of a large network of distributors. They provide in vitro diagnostic solutions that improves patient health and ensures consumer safety. In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. Some of bioMérieux‘s tests are used in laboratory or other health professional settings while others can be used at home. Being in the biotechnology and medical device industry, bioMérieux faces various safety regulations, making it incredibly important to manage contamination risks at each step of the production chain. As the company grew and labeling regulations evolved, bioMérieux underwent an evaluation of its labeling environment.

Headquartered in France, bioMérieux’s labeling environment had a variety of barcode labeling software solutions including BarTender by Seagull Software. Having disparate systems, made it increasingly difficult and inefficient for bioMérieux to train employees on a variety of applications, to perform updates, and to manage consistency throughout their environment which in turn caused manual errors throughout the entire process. “Our current labeling solution didn’t allow us to be centralized within our environment, that was a necessity when finding a new solution for bioMérieux,” states Jérôme Foltz, IS Manufacturing and MDM Domain Manager.

Additional challenges bioMérieux experienced with their unstandardized labeling environment included:

• Low label quality grades
• Inconsistency creating GS1 and UDI (Unique Device Identification) labels
• Manual processes which resulted in unnecessary errors
• Individual installs for multiple label designers resulting in incorrect label creations and inefficiencies in change management

With over 15,000 products, access to labels by over 400 employees, and more than 300 product, shipping, and inventory labels, bioMérieux knew they needed a single provider who had a reliable barcode labeling solution and could offer a standardized solution for their entire labeling environment.

Solution

bioMérieux worked with Barcodis, a French manufacturer and leader in industrial printing solutions, to find a barcode labeling provider and solution for them. bioMérieux found, with Barcodis’ guidance and their long-standing experience with TEKLYNX software applications, that TEKLYNX was the best solution to provide a standardized solution that would adhere to all the regulatory requirements they faced and would provide reliable software now and into the future. bioMérieux chose TEKLYNX to be their barcode labeling solution provider due to:

• The seamless integration of TEKLYNX labeling software with their business system, SAP ERP Central Component (ECC)
• TEKLYNX’ understanding of bioMérieux’s business and labeling regulations such as UDI and CFR (Code of Federal Regulations)
• The superior printer driver compatibility from TEKLYNX with bioMérieux’s plethora of printers, including Zebra, Avery, Opendate, Videojet, Lynx, CAB, Epson, Ricoh, SATO, Markem-lmaje, and Domino
• TEKLYNX’ ability to completely centralize their entire labeling process from design to print

bioMérieux collaborated with Barcodis and the TEKLYNX Enterprise Team to determine that TEKLYNX CENTRAL’s integrated label management system and browser-based interface would meet bioMérieux’s labeling requirements while also providing the support they needed along the way. With the vast number of label templates and printers they had to manage to, TEKLYNX CENTRAL helped bioMérieux easily manage their label templates centrally while ensuring GS1 and UDI compliant labels. “Being in the biotechnology industry, compliance and accuracy are incredibly important for the success of our company as a whole. With TEKLYNX CENTRAL we were able to accomplish all of our labeling goals,” states Foltz.

TEKLYNX and Barcodis recognized how important it was for bioMérieux to standardize and centralize their labeling process while also complying with a multitude of regulations and standards. One of the most crucial regulations they must comply with is the US FDA 21 CFR Part 11 which requires electronic signatures and full transparency into the labeling process. The TEKLYNX Enterprise Team and Barcodis partnered closely with bioMérieux throughout the entire implementation process to ensure the requirements of 21 CFR Part 11 were met.

Results

Once bioMérieux implemented a standardized labeling process with TEKLYNX CENTRAL, their product, shipping, and inventory labels were consistently compliant with GS1 standards and UDI & CFR regulations. By removing the disparate labeling systems bioMérieux had previously used, their labeling accuracy improved exponentially and allowed the bioMérieux team to have peace of mind knowing that their labels were accurate and compliant 100% of the time. “TEKLYNX CENTRAL has improved labeling efficiency and accuracy for our entire labeling process. It is a solution that allows for seamless labeling operations as well as providing the support we need along the way,” states Foltz.

By standardizing and centralizing their labeling process, bioMérieux gained the ability to:

• Create high quality label designs
• Improve labeling security and tracking
• Operate their company more efficiently
• Meet CFR and UDI regulations
• Increase labeling and print speeds
• Save time and reduce errors by centrally managing 300+ labels in an organized fashion
• Provide accurate GS1 and UDI compliant labels 100% of the time
• Integrate seamlessly with their current business system, SAP ECC

With their newly implemented TEKLYNX CENTRAL solution, bioMérieux is equipped to meet their current labeling needs and are prepared for growth in the future. “We take great pride in knowing that our enterprise-level, integrated label management system improves the accuracy and compliance of labels for bioMérieux, positioning them to keep driving growth within the medical device industry around the world now and into the future,” states TEKLYNX President, Thierry Mauger.

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