JAMES KELLEHER
Generis Enterprise Technology Limited, London, United Kingdom

What does the future hold for Quality Management as smart automation offers new ways to monitor and pre-emptively intervene in pharmaceutical production? Late last year, a panel of experts from Merck, Syneos Health and Accenture, chaired by James Kelleher, CEO of Generis, debated the subject.

The participants were:

• Dr. Heiner Niessen, Head of Application Technology Quality & Compliance at Merck
• Peter Brandstetter, Quality and Regulatory expert at Accenture
• James Man, Quality subject expert and R&D Advisory Managing Director at Syneos Health.

What follows is a summary of the discussion.

HAS QUALITY MANAGEMENT OUTLIVED ITS USEFULNESS?
When asked about the future role of Quality in life sciences, the panel gave their frank views. James Man of Syneos Health suggested that the activity could now be more embedded within everyday operations and improved incrementally, a vision that was supported by Peter Brandstetter of Accenture.

“I think companies will reach a point where they don’t need Quality Management or peo ...