German healthcare firm Fresenius Kabi is implementing a new compliance system from Lorax Compliance in order to meet its extended producer responsibility (EPR) reporting obligations.
Environmental compliance is essential to operations of medical device manufacturers. All manufacturers who place products on the market in the European Union (EU) may be obligated to register and pay fees under packaging waste, WEEE and battery directives.
The new EPR compliance system is able to collate and analyse data gathered from the German firm’s global manufacturing base relating to its products and associated packaging.
In order to ensure compliance and avoid fines and reputational damage, manufacturers have to understand the EU’s extended producer responsibility (EPR) waste regulations, as well as a manufacturer’s legal reporting responsibilities.
EPR regulations make the manufacturer responsible for product packaging, EEE and batteries throughout their entire lifecycle, which obligates the manufacturer to report periodically to national recycling organisations with details of packaging, WEEE and battery usage and to pay fees to ensure EPR.
Fresenius Kabi IT solution architect Edwin de Lepper said: "EPR compliance is an important part of governance for any manufacturer and extracting and managing the required data from a global manufacturing base is exceptionally complex.
"Using the Lorax system means we will have a modern solution that will automate much of the work for us, making the process much simpler and quicker than it has been previously."
Licensed as Software as a Service (SaaS), Lorax’s compliance software is based on Amazon Web Services (AWS) platform, which offers a secure and scalable hosting technology, as well as allows customers to access the system via a multitude of devices, including tablets.
Many medical device manufacturers are currently turning to compliance experts to help and avoid the risk of non-compliance.
Lorax Compliance CEO Graham Margetson said: "Environmental compliance is a critical part of a manufacturer’s operations; non-compliance is not a realistic business option.
"We’re delighted to be working with Fresenius Kabi. Although we are a relatively new company, albeit with 20 years experience in environmental compliance, working with such a global company stands as testament to the functionality and usability of the Lorax system and the quality of our people."