Compliance Group is proud to participate in the 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®, a premier global event bringing together leaders from pharmaceutical manufacturing, regulatory ...

We’re excited to announce that Compliance Group will be attending the Realize LIVE Americas 2026 conference, happening in Detroit, Michigan from June 1–4, 2026. This premier industry event, hosted by ...

Join us for an interactive webcast exploring how artificial intelligence (AI) is transforming manufacturing efficiency. This engaging session will highlight practical applications of AI that enhance ...

FDA issues warning letters to avoid compliance. Warning letters are issued when the FDA finds that a company from the life science industry is out of its way with the regulatory standards in quality ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

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 ...

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, ...

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 ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...

In the intricate landscape of regulated industries, the synergy between Computer System Validation (CSV)/Computer Software Assurance (CSA) and Cybersecurity principles emerges as a critical ...