Founded more than 30 years ago in Switzerland, Electro Medical Systems (EMS)is a manufacturer of micromechanical instruments. As a designer and developer of orthopedic, urological and dental prophylaxis devices, the company has a multinational workforce, maintains three manufacturing facilities in Europe and supports a global distribution network.
With its international distribution network expanding, and with compliance deadlines for medical device Unique Device Identification (UDI) regulatory mandates fast approaching, EMS identified the need to streamline business processes and drive labeling from its ERP system. This approach would enable it to seamlessly print labels to identify all products from purchase to delivery. Unfortunately, the existing labeling solution could not support these new requirements. It required manual procedures and did not offer capabilities to meet evolving customer and regulatory requirements.
Also, there were serious issues with label print speed, which had a considerable impact on production. Print performance was exacerbated by significant challenges in maintaining quality with the existing labeling process, which often resulted in mislabeling. Ultimately, EMS recognized that all of these challenges could result in fines, recalls, issues with customer satisfaction and ultimately loss of business. With all of the pending risks and requirements, EMS understood that it would need to identify an enterprise labeling solution to efficiently do business across its global supply chain.
Meeting UDI Requirements
With evolving requirements in the medical device industry, EMS knew it needed to be prepared to meet new regulations. To continue doing business in the United States, EMS needed to obtain certification from the FDA for all products being sold in the United States. With UDI requirements, EMS would need to have traceability for all of its products by serial number and lot number, offering visibility at every level of packaging. However, the company's existing labeling solution did not offer the flexibility needed to meet standards and support required symbologies to adhere to these new mandates.
Also, with the existing labeling system, it would be difficult to ensure accuracy, and ultimately compliance to UDI, since the existing solution involved printing PDF templates and then manually entering serial numbers. This posed a significant risk, since the impact of shipping products through the supply chain with the wrong serial number could ultimately block sales of EMS's devices in certain countries.
Eliminate Occurrence of Mislabeling
Considering the existing system required manual processes, EMS was faced with a critical quality issue. In many cases, incorrect information and even wrong serial numbers were being entered and printed on labels. Additionally, the existing process was difficult because a new label template was needed for each product and business users were in many cases selecting the wrong template.
This error-prone process resulted regularly in mislabeling, ultimately delayed response times, and created problems with customer satisfaction, which could result in returns and fines.
Additionally, the mislabeling issue hindered the company's supply chain efficiency in providing products to its global network of distributors. The company wanted to simplify its labeling approach so business users could print labels without needing to do any manual entry, which would greatly reduce the occurrence of mislabeling.
Improve Print Performance to Meet Production Requirements
When EMS made the change to drive labeling from its ERP system it was faced with a serious print performance issue. The company's legacy labeling system could not print quickly enough to keep up to speed with the production volume. EMS had planned to trigger labeling from its ERP using Crystal Reports and a print server to handle the printing of labels. However, it realized this legacy system was overloaded and could not come close to meeting the speed needed to match production, which required labels to be printed in five seconds or less.
Making matters worse, EMS had already begun shifting the labeling process to the ERP system and found it was faced with a tenuous situation in which it needed to identify and implement a new labeling solution in a matter of two weeks in order not to disrupt production.
Solutions
After the initial setup of a server test environment, EMS found that Loftware's Enterprise Labeling Solution could address all of its existing challenges, including helping the company meet pending UDI regulations and address its critical print performance issues. As producer for the global medical device market, Loftware provided EMS with an enterprise labeling solution to meet its complex labeling needs including regulatory and customer requirements.
Configurable Business Rules
"Loftware business rules will enable EMS to define logic to streamline and remove risks from label printing in order to address mislabeling issues, while providing a platform to address unique requirements including UDI regulations. This business logic functionality helps to eliminate failure points, allows users to simply enter field values to dynamically select printers and templates, populate label data and apply conditional formatting," said a company spokesperson.
Centralized Application Integrated with Business Processes
Loftware's centralized approach, allows EMS to integrate with its existing ERP system and drive data from a "single source of truth," which offers greater control. By using a central database, EMS was able to avoid the need to replicate data, which reduces errors and offers improved labeling consistency for global deployment to other plants and distribution partners internationally. "This ultimately provides a new level of consistency, simplifies troubleshooting and streamlines processes for EMS, while offering the opportunity to scale globally," said the spokesperson.
Automated Print Process
The new automated process allows business users to initiate labeling from the ERP system and eliminate the need to manually input serial number data. Most importantly, the new automated process allowed EMS to achieve significant printing performance gains, allowing labeling to keep up with production. "In addition, now with Loftware Enterprise Labeling Solutions, EMS is able to initiate print jobs in an easily supportable way and greatly reduce the occurrence of mislabeling," said the spokesperson.
Results
"Within a two-week window, a Loftware Enterprise Labeling Solution was deployed so that EMS would not see a disruption to its production. EMS has achieved significant results from the deployment, including the ability to meet UDI compliance requirements, significantly improve print performance, complete eradication of mislabeling and dramatically simplified maintenance," said the spokesperson.
For more information contact:
Loftware, Inc.
166 Corporate Drive
Portsmouth, NH 03801
603-766-3630
www.loftware.com