As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations.

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

Software as a medical device (SaMD) is a growing sector in medical device technology.

As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever.

With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists?

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from

How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions?

Much has been written about the challenges associated with AI-based decisions.

When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal.

Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices.