Infrastructure Qualification


Infrastructure Qualification

Applications that control or support business processes are an essential part of a business’s success. You have to ensure patient safety, product quality, and data integrity through the validation of these applications.

Like any software, however, these applications depend directly on the underlying IT infrastructure. If the infrastructure is not or only insufficiently maintained, there exists a risk that the systems can or will be compromised or that data will be manipulated. For this reason, infrastructure qualification is part of GxP compliance and is explicitly required from a regulatory perspective (Annex 11).

Increasing complexity, virtualization, outsourcing in the form of infrastructure, platform or software as a service (XaaS), present major challenges to the qualification of the infrastructure. The initial stages of infrastructure qualification can be difficult and raise many questions:

Our responsibility, our standard

Thescon can help you in dealing with these questions. In addition to initial training, we assist you with the complete qualification of new or existing IT infrastructures and take IT security (ITSM) compliance into account.

Whether you host the applications on your own servers or whether you buy the software as a service, we work out a strategy customized to your company for the qualification of the infrastructure and will find the most efficient solution for you.


Validation and Qualification

In the regulated industries firms have to comply with extensive and challenging regulations. Such compliance includes the validation of IT systems as well as the qualification of the underlying infrastructure.

Compliance and Quality

A good quality management system is in­dis­pensable in the regulated industries for com­plying with legal stipulations. Further, con­tinuous system maintenance and im­prove­ments to the quality management system con­tributes directly to the success of a firm.

Software selection and Process management

Choosing a new IT software poses a crucial challenge for companies in the regulated industries. Therefore, a well-organized and transparent software selection process is essential in choosing a provider that best suits to the company.

Infrastructure Qualification

Regulated industries must meet important and legal infrastructure qualifications. If the qualification does not follow those guide­lines, unauthorized system access and data manipulation may become real threats to the organization.