Having come from a large Pharmaceutical company, I thought we had some insight that others did not when it came to building IT environments that would pass a company’s Validation efforts. Unfortunately, we quickly found out that most companies in this industry have been so risk adverse that they wouldn’t even consider putting their DEV / Test environments into the cloud, let alone a fully validated system. Needless to say, the Pharmaceutical industry is not what you would consider a “First Movers” when it comes to new technology. We’ve spent years educating the industry about new cloud technologies, how to use them and how they can be safely implemented into their existing IT portfolio – it all fell on deaf ears.
Now, jump ahead. Our business model takes a more horizontal approach to accommodate businesses that are early adopters but we’ve always kept our eye on the Life Sciences industry in one manner or another. Thanks to that diligence and hard work, we’ve begun our first foray into setting up a fully validated QMS environment into Amazon Web Services (AWS). We finally get to flex our IQ/OQ muscles!
To give you a little background on our new client, they’re a local Medical Device Manufacturer here in San Diego. They have a team – both administrative and engineering – that is extremely forward thinking and are a true case study for a project like this. They’re upstarts, savvy technologically and understand risk requirements. Most of all, they’re eager to be free of the traditional hardware implementations that can saddle a company with personnel requirements that are outside of their core competencies.
Our setup will be simple, we’ll build out a tightly controlled AWS VPC, tie it directly to their main office, build out a server environment robust enough to cover their needs but still simple enough to keep things easy and finally write up all the documentation required to fulfill their QA department’s requirements. For those of you who have never built out a qualified / validated environment, there’s more man-hours in documentation and paperwork than in the physical implementation of the environment because, if the FDA were to ever audit the system, the expected level of performance would be that anyone could build out an exact duplicate of the environment by following the IQ/OQ documentation and any subsequent change control forms that have been implemented. You have to prove that there are sufficient audit trails within the environment, as well as tight security to keep any unauthorized people out – at any level of the system.
This is a massive undertaking that requires spectacular attention to detail as well as an intimate familiarity with corporate requirements. A Master Validation plan needs to be in place, IQ/OQ’s need to be thoroughly utilized, change control has to be implemented and used and, most importantly, business process has to be well thought out and adhered to. If any of these are lacking, the entire environment could fall out of a validated state, which would be catastrophic for the company and its product line(s).
I cannot emphasize enough how excited we are to be working on this project. It may be a small implementation but, when these dominos fall successfully, the next project will be that much easier.
If you would like information about how ANTARA can help your QA department put a qualified / validated environment into the cloud we’re here to help!