Pharma 5.0

Pharma leaders must separate AI hype from actionable opportunity, warns NIRAS

Published: 10-Oct-2025

A new report from the company urges pharmaceutical executives to approach AI adoption with trust, transparency and traceability, outlining how the technology can drive compliance and productivity whilst warning against risks from poor data quality and opaque models

The multi-disciplinary engineering consultancy NIRAS has released a new report highlighting AI as a “strategic necessity”.

However, it also warns that leaders must “separate hype from actionable opportunity”.

In the report, ’Harnessing AI in GxP Environments: Innovation, compliance & trust’, experts from NIRAS outline a strategic playbook for pharma and life science managers to unlock the huge potential of implementing AI with trust, transparency and traceability from the start. 

The integration of AI into GxP-regulated environments offers opportunities to enhance compliance, quality and productivity.

However, the report also warns about the risks of poor data quality, the suitability of black-box AI models for GxP applications and the challenges of ongoing updates and recalibration.

Commenting on the analysis, Jesper Madsen Wagner, expert director at NIRAS, said: “The pharma and life sciences industry is entering an era which will be shaped by AI and digital transformation."

"For the industry to navigate this shift, executive leadership must take a proactive role in determining how these technologies are adopted.  

“There’s no doubt that AI is set to transform pharma and life science value chains, but in GxP-regulated environments, innovation must be as disciplined as it is disruptive."

"It’s vital that leadership is equipped to separate hype from actionable opportunity."

“The main message is clear: AI’s future in pharma & life science belongs to leaders who incorporate trust, transparency and traceability from the get-go.”

You may also like