Audits are increasingly key to maintaining business credibility across both operations and outputs, especially as disruptive technologies such as Artificial Intelligence (AI) are increasingly adopted in the workplace.
Since the launch of ISO 42001 in 2023, businesses that develop or deploy AI now have an updated framework for building an AI Management System (AIMS).
What is ISO 42001 and why does it matter for pharmaceutical manufacturers?
ISO 42001 sets out requirements for responsible AI governance across an organisation's entire operations.
For pharma and chemical manufacturers deploying AI in areas such as process analytical technology (PAT), predictive maintenance, regulatory submission workflows, or pharmacovigilance, compliance with ISO 42001 is not theoretical.
It is becoming an operational baseline, particularly ahead of the EU AI Act provisions taking effect in August 2026.
AI is constantly evolving, as are the legal and regulatory requirements surrounding it. Nearly eight in ten of surveyed executives believe their companies would fail an AI governance audit, even as AI adoption grows across industries.
With the EU AI Act coming in August 2026 and standards such as ISO 42001 raising expectations for AI oversight and accountability, many organisations are struggling to meet these requirements from the outset.
Kirsty Wakefield, Information Security Sector Manager at ISOQAR, has shared the top AI governance failures organisations are making in 2026, along with her recommendations for successfully demonstrating compliance in AI audits.
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