Life SciencesRegulations and StandardsComputer System ValidationBlog
Solution for CFR Part 11: Validation for Small/Medium Pharma
Life SciencesRegulations and StandardsComputer System Validation
by Jon Davidson | November 15, 2018
The validation systems and software has traditionally always been a source of great frustration for CROs and small/medium Pharma companies. Investing in and maintaining a validated statistical computing environment comes with a significant price tag, demands a lot of resource, and requires in-house expertise for an area that’s not core to the business.
Not so long ago, major Pharma companies shunned Cloud technology. But today’s landscape tells a different story. Few organisations now want to own their own hardware in a world where it’s so costly to do so, and the existence of certain technology means they don’t have to. All of a sudden, Pharma companies are actively embracing the benefits that Cloud promises.
And as we all know, where the large Pharmas go, small and medium organisations are almost certain to follow, so we expect to see wholesale adoption of Cloud across the industry.
Cloud migration makes sense for these businesses for a number of reasons, and this is likely to have a knock-on effect for validation software.
On-premises software can limit an organisation’s ability to be flexible and agile. So, with attitudes now changing, a move to embrace validated software hosted in Cloud environments is the next logical step.
For PC based SAS Users at Biotech companies in phase 2 / phase 3 or for those in CROs, the irregular requirement for validated platforms means they often sit idle until a clinical trial comes in. So, the cost and physical infrastructure of a non-Cloud platform doesn’t make sense. Cloud is ideal in this situation as you can scale up and down as and when you need it.
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When you consider the cost and resource needed for running and maintaining validated software environments, it’s quite a shopping list. There’s the initial set up of servers, IT resource, installation, configuration, and the commitment of hosting, support and validation for new software releases. Plus, setting up such an environment can take two to three employees between six to nine months to complete. That’s a lot of skill and resource committed to a non-core area of the business.
As such, we expect to see small and medium companies reconsidering their approach and asking themselves if their money and resource could be deployed in a better way.
d-wise, we’re solving this problem by providing Accel the cloud based statistical computing environment, which enables companies to access applications like SAS & R without the regulatory burden associated with clinical programming software validation. For small/medium Pharma and CROs looking to control costs and put a lid on their legislative commitments see our video below.