To eQMS or Not: The Enduring Value of a Traditional QMS in a Digital Age
In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable. Streamlined workflows, instant data access, and automated reporting – it all sounds incredibly efficient. But amidst the digital buzz, there’s still a place for the stalwart, traditional paper-based QMS. While often perceived as outdated, a paper system can offer unique […]
Rethinking eQMS: When a Traditional QMS Might be Right
An eQMS system, or electronic Quality Management System, is a software solution designed to automate and streamline quality management processes within an organization. It replaces traditional paper-based systems with a digital centralized platform for managing documents, workflows, and quality-related activities. While eQMS systems offer automation and streamlined workflows, they aren’t always the best fit for […]
FDA’s Quality Management Maturity Program
In an era where medical devices and pharmaceuticals are becoming increasingly complex, ensuring their safety and efficacy is paramount. The FDA’s Quality Management Maturity (QMM) Program represents a significant step forward in achieving this goal. By focusing on the quality management systems of manufacturers, the QMM Program aims to enhance the overall safety and effectiveness […]
Navigating the FDA QMSR Transition: Expert Guidance for a Seamless Journey
Are you ready for the FDA’s Quality Management System Regulation (QMSR) transition? The FDA’s new QMSR is set to become effective in February 2026. As a complex regulatory change, it requires careful planning and execution to ensure compliance. Don’t wait — get started now! Why Choose AlvaMed? Our team of experienced quality and regulatory experts […]
Internal Auditing
Background and Problem A small start-up with limited resources needed assistance with conducting its required internal audits to maintain compliance with quality and regulatory requirements. The scope of the organization’s quality management system includes ISO 13485:2016 and 21 CFR Parts 820, 803, & 806. Due to the size of the organization and the operating mode, […]
