AI in GxP: When to Deploy and When to Wait

Artificial intelligence is entering regulated operations in pharmacovigilance, manufacturing, and clinical research, but not every organisation is prepared for responsible adoption.

In 2025, regulators in Australia, Europe, and the US introduced new expectations for AI oversight.
The TGA’s AI Review, the EMA’s Annex 22 draft, and ISO/IEC 42001 all send a clear message:

AI may be used in GxP only when governance, validation, and human oversight are established.

Many teams feel pressure to adopt AI quickly, but implementing it without clear roles, defined processes, or data integrity controls can result in inspection findings, compliance gaps, and patient safety risks.

How can you determine if your organisation is ready?

I have prepared a detailed overview covering:

• Six criteria for deploying AI with confidence

• Eight red flags that mean “not yet”

• Human-in-the-loop requirements

• Vendor qualification essentials

• Data governance and ALCOA+ expectations

• The Australian regulatory trajectory for AI-enabled GxP systems

Read the full article on GxPVigilance:
AI in GxP: When to Deploy and When to Wait

If you are navigating AI adoption in a regulated environment or need guidance on oversight, validation, and risk management, please don't hesitate to reach out.

Responsible AI in GxP isn’t about speed.
It’s about clarity, control, confidence, and patient safety.

— Carl