Whtie Paper: Medical Device Manufacturers Can Leverage ERP/CRM Software To Facilitate FDA Compliance

While every manufacturer in the United States is subject to a multitude of government rules and regulations, probaly no industries are as fully regulated as those dealing with food, pharmaceuticals and medical devices. The U.S. FDA(Food and Durg Administration)requries companies in these segments to comply with standards for quality, saftey, effectiveness, identity and strength Because the burben is on the manufacturers to prove conformity, they are forced to employ costly. strigent procedures, maintain in-depth documentation and generate a myraid of substantiating report.

Medical Device Manufacturers, similar to other manufacturers, have long embraced ERP(Enterprise Resource Planning) and CRM(Customer Relationship Managment) software systems. However they have primarily employed them to achieve operational effeciencies as well as future sales and marketing objectives. Indeed. todays sophisticated ERP and CRM systems support a broad set of activites that help manage and coordinate business functions. including production planning, purchasing, inventory control, supplier interaction, order tracking and customer service. However, many Medical Device Manufactures have also discovered that their choice of ERP and CRM software can play a significant role in their abilities to comply with strict FDA regulations.

Basically, the FDA requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical devie(s) designed or manufactured. The quality system has to be an integrated effort, ie., a total systems approach to satisfy the particular safety and performance needs of a specific manufacturer product and user – market. The quality assurance activites have to extend beyond inspection and testing spot solutions and must cover all areas that have an effect on the quality, safety and effectiveness of the device. These areas include product development, design verification and validation comment and/or supplier selection documentation development of labeling, design transfer, process development and validation, pilot product, routine manufacturing, test/inspection, device history record evaluation, service or repair and complaints, FDA insepectors expect firms to have strong CAPA corrective & preventative action program) systems that permeate a operations to ledden recalls and investigations as well as to reduce ability, miligate product loss and promote profitability.