One Company’s Path to 21 CFR 11 Validation
One Company’s Path to 21 CFR 11 Validation
12 PagesOne Company’s Path to 21 CFR 11 Validation This case study describes how ISI Group selected and validated a document management system for compliance with the United States Food and Drug Administration (US FDA) electronic record and electronic signature (21 CFR part 11) regulations. It was written by a employee of the ISI group for FileHold Systems. Background ISI Group, LLC is a small virtual organization of consultants and contractors. They develop and sell medical image storage, display, and management software for use in hospitals and other healthcare facilities. In the United States, most varieties of medical image-handling software are classified as medical devices by the US FDA, and companies that sell the medical device software must comply with US FDA regulations. In broad terms,
