The bar for what constitutes an “enterprise” regulatory technology platform has crept steadily higher during the past decade.
Ten years ago, a quality management system (QMS) with cloud functionality and electronic submissions might have qualified as enterprise.
Today, forward-looking mid-tier manufacturers require a robust electronic QMS and regulatory information management (RIM) solutions with built-in artificial intelligence (AI) capabilities to stay competitive.
What has not changed, and is unlikely to, are the harsh realities of GxP-regulated software ownership and the hidden costs of buying too much technology.
Mike King, Senior Director, Product and Strategy, Quality, Regulatory, Safety and Detect at IQVIA, takes up the story.
Consider a mid-tier pharmaceutical manufacturer that spends more than £500,000 per year on quality and regulatory software only to find that their team regularly uses less than 50% of the functionality they pay for.
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