Regulatory compliance can prove complex and demanding for manufacturers in just about any sector, but organizations in segments handling sensitive materials or highly specialized equipment types can face particularly demanding circumstances.
This was the situation Optovue faced, as the global ophthalmic imaging equipment provider had to deal with a demanding regulatory shift with cascading effects across the supply chain.
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Initially, the equipment-maker faced new FDA requirements surrounding the need to label components with a Unique Device Identifier. This meant the organization had to completely adjust its practices and capabilities to achieve compliance. By working with RFgen, the company was able to deploy a mobile data collection system to process inventory transactions.
In practice, the solution allowed Optovue users to handle bidirectional communication between mobile devices and their ERP setup, making it easier to identify when labels need to be created, grab relevant data from the ERP software, print a barcode and track transactions.
However, complying with the then new UDI standard was only the first part. The system was created with flexibility and adaptability to support other label formats and customize data as needed. This functionality has empowered the manufacturer to respond to shifting global regulations across all of the marketplaces it serves.
The strategic data collection and integration improvement set a foundation for continual adjustments to regulatory changes.
Learning From Optovue
"Manufacturers can face scrutiny from a variety of regulatory bodies."
Manufacturers can face scrutiny from a variety of regulatory bodies across many components of their supply chains. Employees need tools that let them properly document their day-to-day work to create audit trails without disrupting operations. In the past, this kind of flexibility wasn't possible. Organizations would typically need to wade through massive quantities of paperwork - daily cycle counts, shipping manifests, invoices, etc. - to complete an audit and track compliance. With mobile data collection systems that integrate with an ERP software, organizations can track everything digitally without manual data entry and pull audits directly from the ERP interface.
RFgen was able to help Optovue handle the new regulations it faced, and we can do the same for you. Whether your business is looking at new regulations on the horizon or is trying to streamline and advance current processes, we can help. Contact us today or check out our full Optovue case study to learn more.