The Cloud… everyone is talking about it, technology companies are embracing it, while Life-Science companies are wrestling with “how to validate it”.
This trend was evident during my discussions with QAD’s executive management team at company’s Explore conference.
QAD is making a significant investment in migrating customers to its Cloud based ERP offerings. “One very interesting and exciting thing is that our Cloud revenue has increased about 35 to 40% a year over the last few years” said Karl Lopker, CEO at QAD. “ Our Cloud revenue is now about 10% of the company’s revenue and is increasing at such a rate that it will be a major portion of our revenue in the future, he added”
The push to the Cloud was also evident in the many sessions dealing with this topic. These included:
- Building a Business Case for the Cloud
- QAD Cloud ERP Conversion Process
- QAD Cloud ERP: Life After Migration
During his Life-Sciences session, David Medina, Vice President – Life Sciences at QAD, discussed the company’s perspective on “5 Things to Consider in a Life Sciences ERP.” Top on his list was “Should you move to the Cloud?”
When we talk to Life-Science industry executives considering Cloud based applications, the top question we get goes something like this: How do I validate a Cloud Solution which is distributed, elastic and scales on demand?
Medina, explained that QAD offers Life-Science companies “a full featured ERP solution on a qualified IT environment that’s operated with regulatory compliant SOPs.” He continued “QAD’s approach is to provide each Life-Science customer with a dedicated, single instance that allows them to control patch applications and upgrades so that they can sync their validation requirements with implementations.”
Bobby Yeomans, Manufacturing Technology Director at Med-Tech manufacturer Facet Technologies, discussed the companies experience with QAD’s Cloud ERP.
According to Yeomans, “Facet chose the QAD software because of its focus on manufacturing and proven experience in the life sciences vertical.” The company decided to use the Cloud solution due to the plan to reduce head count. “QAD provides a full time staff to manage the server and application and the Cloud allows us to focus on our business practices and improvements,” said to Yeomans
In October 2013, Facet used QAD’s validation tool kit to perform a full system validation of the Cloud ERP solution.
“The Cloud experience has been really successful’” said Yeomans. “We experienced the initial hesitancy giving up “control” of the server, but the on-demand team has been very responsive and they keep me informed with monthly meetings. Performance and uptime exceeded goals, with 99.8% system availability to date,” he added.
Another question we often get when discussing the Cloud with Life-Science industry executives is: “Do you know when FDA will issue new regulation to deal with the Cloud?”
I often answer with this question: do you really want more regulations?
I got this very question from the audience while moderating the Life-Sciences Executive Panel at the QAD Explore conference.
FDA has already issued regulation for dealing with the Cloud, I replied. (See Validating the Cloud for details.)
As technology companies continue to shift to the Cloud, Life-Science companies will embrace Cloud solutions. However, they must recognize that traditional on premise & closed system approaches to validation are not applicable to the Cloud. Life-Science organizations must develop approaches that comply with an “Open System” reality where system access is not controlled by those responsible for the content of electronic records that are on the system.