Changing Roles in the QMS Cloud Validation Model

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With the shift comes a change in who performs what roles in the validation process. Let’s look at this new responsibility landscape.

Who plays what roles

Who does what in the Validation model can change when we move to the Cloud. The customer remains responsible for, on the front end, validation planning and user requirements, and on the back end, user acceptance testing and validation reporting.

The software provider can assume responsibility for system requirements, detailed design, system configuration and development, unit/integration testing and system testing. The cloud provider can now look after the technical architecture and IQ.

Change control – private cloud vs. public cloud

Life sciences companies can tap into a wealth of innovative software that is being developed at a rapid rate – but it comes at a price. Every time new or improved software is introduced and adopted, it is accompanied by an additional revalidation cost.

In the traditional and private cloud models, customers have full control over software changes. They can review new releases and patches from their software vendors and introduce changes at their own pace.

In the community and public cloud models, the software provider controls software changes. To increase the level of flexibility a customer has over the processes, the concept of feature toggles is becoming more widely used. In this setup, the software provider publishes its upcoming changes before releasing them. The customer then reviews, assesses and accepts the changes prior to deployment.

Using change controls, a company can elect to either turn on a feature and use it or simply leave it turned off. Features are typically organized by either modules or types of documents supported by a department. Examples include controls around document management, training management or complaint management.

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


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