FDA 21 CFR Part 11 & UDI Compliance
In the early 1990's the Food and Drug Administration (FDA) began developing regulations to make use of the latest technologies to protect the public health. Specifically, they estimated that they could save $3.1 billion annually and prevent 13,000-26,000 deaths a year from direct and indirect medical device procedure/process infections.They believed that creating product identification standards would also reduce theft and counterfeiting of medical devices, improve health provider’s processes, increase patient safety, and generally improve the quality of care.
As a result, most food, drugs, medical devices, and cosmetics distributed in the United States today must comply with labeling regulations published by the FDA. The FDA 21 CFR Part 11 regulations go beyond traditional labeling to include other written, printed, or graphic matter on or accompanying a product.This also includes printed materials used for production processing, product components, quality assurance documents, packaging, labeling, installation, maintenance, and servicing documents.
In addition to the FDA, OSHA, DOT, other government agencies enforce strict requirements and regulations governing product identification, labeling, and shipping. As a result, most world class manufacturers and life science companies appropriate significant resources to comply and minimize errors. However, merely appropriating a large amount of money does not guarantee efficient results.
enLabel is the premier packaging management software system available for pharmaceutical and medical device labeling and packaging. From its inception, enLabel has been designed to comply with the U.S. Food and Drug Administration GXMP’s and the ISO 9000 series of international standards. Regular updates guarantee that enLabel complies with the latest regulatory trends in the industry. enLabel Global Services has incorporated additional security features and new technologies in their software solutions so they are fully 21 CFR Part 11 compliant.
enLabel solutions and compliance services reduce costs, and improve accuracy, and operational efficiency while complying with FDA 21 CFR Part 11 and UDI regulations.