QMS Validation: Changes in the Cloud

Many companies in various industries are turning to the Cloud Computing model to validate their Quality Management Systems. This shift brings with it many changes to the traditional on-premises approach. Let’s look at what has changed in the cloud…and what hasn’t.

A key element in any software validation process is the Installation Qualification (IQ). This is essentially a checklist to ensure all elements needed to effectively run the software are in place. Questions to be answered include whether the software was loaded correctly and whether there is enough memory. The Cloud model’s architecture introduces new elements that companies must be aware of, as these pertain to the validation process.

Regulatory expectations for cloud providers

The traditional and the Cloud architecture share the same basic structure. It consists of:

  • A development environment, where applications are created
  • A test environment, where the recently developed software is tested exhaustively to make sure it does what it is supposed to do
  • A production environment, where the final, live version of the software sits
  • A backup environment, which houses an identical copy of the final version of the software lest something happen to the in-use version.

The architecture of the Private Cloud model mirrors the traditional architecture. The only differences are that the servers and additional infrastructure pieces are housed on the cloud provider’s premises, and that the cloud provider performs the IQ.

One significant difference between the traditional model and the Community and Public Cloud models is in the actual servers themselves. All servers are virtual in these setups, as opposed to being individual machines. These are used so that cloud providers can house exponentially larger numbers of clients than they could on individual servers dedicated to a single customer.

This, however, creates a challenge when trying to pull information on an individual client for the purposes of an IQ. Where before it was simple for a company to find its data because the servers were their own and no other companies’ data was present to create any confusion, in the virtualized cloud, the abundance of data makes it next to impossible to extract pinpointed data for an IQ.

Cloud providers instead capture data from across their virtualized environment that is representative of whatever parameter is being requested to satisfy the requirements of an IQ, such as available memory. This data is then used to help establish that the IQ has been carried out appropriately. According to Glemser, the method is being well received by life sciences companies looking to satisfy regulators.

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


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