Harness the Power of AI in GxP – East 2026 brings together industry leaders, innovators, and compliance professionals to explore the evolving role of Artificial Intelligence in regulated life sciences ...

Speak with one of our AI compliance experts and find out how Compliance Group can help your organization adopt and validate AI with confidence.

AI Governance, CSA, Data Integrity, GRC, Risk Management, and Inspection Readiness. Built for FDA-regulated life sciences.

For quality leaders navigating FDA’s CSA guidance, AI governance requirements, and the pressure to modernize without breaking compliance—this is the guide that ...

On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards - Premarket approval (PMA), which requires ...

In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Furthermore, it discusses the processes and practice's dependability, ...

Envision a not-so-distant future, when logging into your computer opens the door to an instantaneous digital replica of your company's manufacturing line. In this virtual world, a constant stream of ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...