While every manufacturer in the United States is subject to a multitude of governmental rules and regulations, probably no industries are as fully regulated as those dealing with food, pharmaceuticals and medical devices. The U.S. FDA (Food and Drug Administration) requires companies in these segments to comply with standards for quality, safety, effectiveness, identity and strength. because the burden is on the manufacturers to prove conformity, they are forced to employ costly, stringent procedures, maintain in-depth documentation and generate a myriad of substantiating reports.
Medical Device Manufacturers, similar to other manufacturers, have long embraced ERP (Enterprise Resource Planning) and CRM (Customer Relationship Management) software systems. However, they have primarily employed them to achieve operational efficiencies as well as future sales and marketing objectives. Indeed, today's sophisticated ERP and CRM systems support a broad set of activities that help manage and coordinate business functions, including production planning, purchasing, inventory control, supplier interaction, order tracking and customer service. However, many medical device manufacturers have also discovered that their choice in ERP and CRM software can play a significant role in their abilities to comply with strict FDA regulations.
