Medical Device Link.

The task of evaluating and selecting a business system that will essentially run your business and help you meet U.S. Food and Drug Administration (FDA) requirements can be a daunting project. The purpose of this white paper is to provide you with an overview of the process, based on the twenty two years of experience in helping manufacturing companies choose an Enterprise Resource Planning (ERP) system, including 100+ Life Science customers whose manufacturing must meet FDA requirements. This paper assumes you are looking for an ERP system that supports FDA requirements. Non-regulatory issues common to the acquisition of an ERP system are also covered. Whether your company is a diagnostic product manufacturer, a medical device manufacturer of a pharmaceutical manufacturer, you are well aware of the consequences of failing to meet current Good Manufacturing Practice (cGMP) requirements. The most critical requirement for an ERP system operating in an FDA-regulated environment is "cradle to grave and grave to cradle" lot traceability. In order to submit this kind of information to the FDA, the system must be validated. Many companies are being proactive and getting their systems validated before an event such as an FDA inspection, a product complaint or in the most extreme case, when a product recall occurs. Having their ERP system validated gives the company and the FDA assurance that the company has control over their manufacturing processes and that they can quickly and easily identify product components by lot. However, the most useful task that lot traceability performs is quickly answering questions about the sources and destinations of all products and components. Provided by: Fourth Shift