It happened to be one of 18 global sites in a prior company that our founder, Panos was affiliated with, all of which were running manual quality systems [read: paper/pencil/Excel] and hosting several regulatory and client inspections each week.
Panos watched this facility with a proud pedigree of development innovation and GMP compliance struggle to resolve the findings using the tools at hand. An electronic QMS would certainly have helped, but the cost, timing and complexity of implementing a solution made this a non-option. The site (and the company) just didn't have the experience or resources needed to implement what everyone thought of as 'gold standard' solutions at the time—it would have taken years and millions of dollars to get it right. And then what? Does all the configuration, customization and validation mean the site has one foot firmly in the "regulated software" space forever?
An eQMS is absolutely necessary for today's complex regulatory environment, especially for life sciences companies. But options were far too limited and complex for everyone to access. And so he joined forces with Graham Wert, who also had strong experience with GxP software, to develop a better platform built around simplicity and transparency that was actually attainable for any company.
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