The New Partnership-Based Landscape of QMS Validation

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With this shift comes many changes, including a new emphasis on partnerships. Let’s look at this new partnership-based landscape.

Three’s company

With more than two parties (traditionally the customer and the software provider) now involved in the validation process (the cloud provider has now added to the mix), the concept of the typical Service Level Agreement (SLA) changes in the cloud. It’s important, says Ray Glemser, CEO of IT solutions and services provider Glemser Technologies Corp., for a customer to recognize they are now in partnership with the other two players, who are performing more specialized functions for them.

“These are tied together in what we used to call an SLA,” Glemser says. “We are now organizing them into quality agreements where the quality system validation state needs to be maintained by multiple organizations, rather than just one. It is very important to get the roles correct, the business relationships established, and the procedures in place at the different organizations to support these Quality Management Systems in the cloud.”

Looking ahead

Many organizations, Glemser points out, have moved their QMS validation efforts into the public cloud and are realizing significant benefits, including lower costs, the ability to focus on core business concerns rather than merely “keeping the lights on,” and access to leading software products and expertise.

“They’re not going to turn back, and it’s only a matter of time before everybody gets comfortable with it,” Glemser says. Yes, there will always be stragglers, he adds. The life sciences industry, in fact, is one of the most conservative in its willingness to move into the cloud.

“But many industries are already here, and the fact that people are successfully surviving audits while operating in the cloud will continue to push the pendulum to this side.”

To learn more about QMS validation in the Cloud, download our free Definitive Guide on the subject today.


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