LivaNova is a global medical technology and innovation company headquartered in London and with a presence in more than 100 countries. For almost 50 years, LivaNova has created leading products and therapies within the areas of advanced circulatory support, cardiopulmonary, and neuromodulation. The company aims to deliver life-changing improvements for both the Head and Heart through innovative medical technologies.
LivaNova’s labeling operations include producing labels for the company’s finished products – such as oxygenators and autotransfusion systems – and individual product components or semi-finished products. LivaNova’s internal manufacturing departments in Mirandola and Medolla, Italy are responsible for product and packaging label printing. The company also uses four external suppliers in Italy and Slovenia to produce products and print the associated labels.
As a medical device company, LivaNova must comply with a wide range of regulations in the countries where it does business. The company wanted to implement a standardized label printing solution with a built-in approval workflow that would support its compliance initiatives. As one of LivaNova’s business units was already successfully using Loftware, the company decided to expand the platform to the rest of the organization.
In their previous labeling process, LivaNova used a manual approval process. Employees created paper templates to manage new label layouts and requests for label creation and modifications. All approval workflows happened outside of the company’s systems. Once a label was approved, the designer would create it with graphic design software.
Using Loftware workflows, which automate the routing of label documents for review and approval, LivaNova has partially eliminated manual and disparate quality approval processes with a goal to remove the paper template completely in the near future. The digital approval workflow now includes the regulatory team, Research & Development, and the documentation office to review, compare, reject, or approve label templates. Electronic signature within Loftware represents an additional security measure in LivaNova’s automated label approval process which prevents unauthorized users from making label changes.
We chose Loftware because we needed a stable, standardized labeling process throughout the company.
Annamaria De Padua
IT Project Manager
LivaNova’s previous labeling system was a custom solution that wasn’t integrated with DIRIMO, the company’s packaging line control system, and only partially integrated with the Enterprise Resource Planning (ERP) system. Users could import data, but they weren’t able to send the print data back to the ERP system. Now that Loftware is fully integrated with both systems, all the printing data is transferred back to the ERP system. Loftware's complete print history with a graphical view of every label ever printed throughout the entire organization, combined with the audit trail capabilities, gives the LivaNova team the traceability they require to improve regulatory compliance.
LivaNova was also looking for a reliable maintenance team that could support its labeling system. The previous labeling solution had been developed by a small supplier, so it wasn’t always easy to get the support that they needed. Now, with Loftware, they have a business partner that can provide round-the-clock software maintenance support in all the countries where LivaNova operates.
