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GxP Cloud Part 4 of 6: Stuck on the Ground While They’re in the Cloud

With many hosting vendors often unable or unwilling to meet regulatory compliance guidelines, or to at least work with potential customers to assist in meeting those requirements, most Life Sciences teams continue to opt to manage infrastructure and applications internally.  In a highly regulated industry, sometimes maintaining in-house control is the safest way to proceed, but it also comes with cost and resource burdens. 

Instead of being able to offload tasks associated with infrastructure and application administration and management, Life Sciences teams continue to either rely on dedicated resources to manage these tasks, or worse, they must count on team members to split their focus and manage these tasks in addition to their normal activities.  Either way, it becomes an added layer of complexity that can get in the way of productivity. 

In an ideal world, these time consuming and tedious tasks can be taken off a team’s plate and passed along to a qualified vendor, but as discussed, this has typically been difficult for a Life Sciences team to find. 

Regardless of where the infrastructure resides, in a regulated industry, the onus of verifying the qualified state of that infrastructure will always fall to the regulated organization. 

On the actual software validation side of things, internal application ownership definitely has its benefits over a SaaS or hosted software solution as the control stays 100% in the hands of the team responsible for it.  Without application control, organizations are be subjected to a steady flow of patch releases and version upgrades.  This is fine for non-Life Sciences teams, but keeping up with multiple patches per year and 1-2 full version upgrades a year in a regulated environment is not realistic or productive for a validation and testing team.  The burden of re-validating or constantly performing UAT simply becomes untenable at this pace. 

Ultimately, both the human and technology resource constraints of internal application and infrastructure ownership prove costly and impeding to larger software, quality and business goals relative to streamlined hosting options.  The truth, at least at first glance, is that in-house ownership still has the appeal of being the least risky option in an extremely risk-averse industry.   

If major hosting providers aren’t able to comply to the regulations that Life Sciences teams have to abide by, or at least not easily, then what other options are there?  As with most struggles caused by niche industry requirements, teams working in a regulated environment need to look beyond the surface level to align with providers in more of a strategic, common goal partnership, rather than simply looking for a service provider. 

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