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 ...

AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations. But while ...

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 ...

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 ...

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 ...

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 ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...

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 ...

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 ...

Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity ...

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