21 CFR 820 and ISO 13485 are two distinct sets of quality management system (QMS) standards that are relevant to the medical device industry. While they share some similarities, there are also notable differences between…
Computer software assurance in the context of the FDA (U.S. Food and Drug Administration) refers to the processes and practices employed to ensure the reliability, integrity, and security of computer systems used in the…
A Paperless Validation system refers to a digital or electronic approach to validating and verifying various processes, documents, data, or transactions without the need for physical paperwork. This system is often used to…
Effective document control is essential for organizations of all sizes and industries to maintain compliance, improve operational efficiency, and ensure the integrity of their records. This blog post provides a comprehensive…
Non-Conformance Reporting (NCR) is a vital quality management process that involves documenting and addressing instances where a product, service, process, or system deviates from established standards, specifications, or…
Uncover the power of eQMS Software in ensuring seamless compliance within the dynamic Bioscience industries. 🌱🔒 đź“Ś Staying compliant is the cornerstone of success in Bioscience. Our comprehensive white paper explores how an…
🔍 Unlocking Medical Device Safety with ISO 14971  Discover the roadmap to uncompromised patient safety with our latest white paper on ISO 14971! 🏥🔒 đź“Ś In the world of medical devices, ensuring safety is paramount. Compliance…
FDA 21 CFR Part 11 is a regulation that sets forth the criteria for the use of electronic records and electronic signatures in industries regulated by the U.S. Food and Drug Administration (FDA). It is particularly important…
Welcome to another insightful episode of Compliance Group in navigating compliance Excellence in the Life Sciences Industry. In today's episode, we're diving deep into the evolving world of computer system…
Welcome to another insightful Blog from Compliance Group. In this blog, we're delving into a critical aspect of medical device development and manufacturing – packaging and sterilization validation. These processes are…
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