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Cloud Validation – Management Of Trust

The use of cloud services is a worldwide challenge for companies acting in regulated environments. While traditional on-premise solutions convey a sense of control and security, cloud solutions require a lot of trust and give the impression of a loss of control. Major administrative and operational tasks are outsourced using cloud-based IT infrastructure (IaaS), platforms (PaaS) or software (SaaS). In a GxP environment in particular, a lack of collaboration, data integrity and security issues are seen as high risks and tend to deter companies from using cloud services. Advantages like cost effectiveness, standardization and flexible data access are not being used as the risks involved seem to be greater than opportunities offered.

Is the use of cloud services in a GxP environment a “no-go”?

No. However, the implementation of cloud services requires a precise definition of activities, timelines, roles and responsibilities, rights, facts (service level and costs) and – not to be ignored – trust. There are two key tasks at the beginning of any cloud service implementation that are essential in meeting these challenging requirements: Effective vendor selection and well-thought-out Service Level Agreements.

Vendor Selection and Service Level Agreements

Vendor selection forms the basis for trust-based collaboration and project success. It is important to ensure that vendors meet important customer requirements and that close collaboration is possible – on both a technical and a human level. Once a suitable vendor has been found, the framework for the successful collaboration has to be defined in a Service Level Agreement. Both the vendor and the customer have to be aware of their rights and obligations, the service scope must be clear and the possibilities for mitigating GxP risks have to be taken into consideration when creating the agreement.

Choosing the right vendor and a well-considered Service Level Agreement are essential for successful cloud implementation. These two activities mitigate the major risks of a cloud implementation project and are prerequisites for safe cloud operation.

New product developments in the technology sector mean increasing challenges for companies in regulated environments. Nevertheless, there is no need to stay below ones best – new technologies and regulatory compliance can be reconciled by keeping an open mind and deploying a solution-focused approach. There is no need to miss great opportunities!