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 ...

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

In regulated environments across the pharmaceutical, MedTech, and biotechnology sectors where AI, data integrity has traditionally evaluated through presence, completeness, and traceability of ...

CLAiRE, iQuality, and MAiGRATE are purpose-built for the one constraint generic AI ignores: every claim has to trace back to your organizational truth — not a model's training data. Most life sciences ...

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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 ...

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 ...

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 ...

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 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 ...