As AI adoption accelerates across life sciences, organizations face a critical challenge: determining when AI becomes relevant to GxP compliance. But is asking whether an AI solution is GxP or non-GxP ...

An FDA inspection letter goes hand in hand with running a business that produces medical devices. It is important to note the impact of inspection results on the organization’s operations. The ...

Implementation of AI solutions is evolving quickly from experimentation to operational deployment within the life sciences industry. Currently, AI-powered tools are deployed for pharmacovigilance ...

than the system you're validating. Compliance Group's AI Test Management solution — powered by CLAiRE AI Agentic Platform — automates requirement analysis, test case generation, execution, and ...

See how Compliance Group helps life sciences organizations adopt and validate AI with confidence through CLAiRE AI Agents and the iQuality Platform.

In the rapidly evolving pharmaceutical and biotechnology industries, Veeva Vault stands out as a transformative platform for managing critical data and processes. At Compliance Group (CG), we ...

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 ...

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 ...

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

The conventional method for validating computer systems, known as Computer System Validation (CSV), has been in practice since the inception of the United States Food and Drug Administration (FDA) 21 ...