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.


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Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of FDA's 21 CFR Part 820 and ISO 13485 international standard is to ensure medical device quality and safety and to reduce, if not prevent, injuries and deaths.21 CFR Part 820 outlines Quality System Regulations (QSR) for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market.


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ISO 14971 Medical Device Risk Management, Risk management is more than just a buzzword in the medical device industry. It's considered essential — both by ISO and FDA — in ensuring the safety and reliability of medical devices. ISO 14971:2000 (Medical Devices – Application of Risk Management to Medical Devices) is an international standard used by manufacturers as a tool for conducting risk assessment. The FDA recognizes it as an acceptable risk management model and the European Union has made it mandatory.


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The good news is that electronic record retention tools and technologies give firms of all types and sizes unprecedented opportunities to improve their operational efficiencies, speed products to market, make regulators happy, and send black ink straight to the bottom-line. The bad news is that electronic record retention tools and technologies are arguably more advanced than some of the strategies and best practices employed by companies to try and ensure all of those benefits. Worse, some firms commit the well-meaning mistake of trying to be safe by hanging onto every electronic record until their systems are so slowed and clogged that it is hard to find the electronic records they need when you need them.


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