Validation is a service of consulting and strategic supervision over CSV activities. We prepare and verify CSV products, and we are responsible for planning, rationalization and reporting of the validation approach. We do it both in projects and in the operational phase of automatic and IT systems.
During the qualification process, we provide evidence and demonstrate that the system operates in accordance with the established parameters and quality requirements.
Infrastructure qualification consist in ensuring the best performance of IT systems and the operation of the organization that uses these systems. During qualification, a general approach, standards and procedures for existing and new components are developed. In order to manage an effective IT organization, it is necessary to define IT processes well and to establish how IT manages new parameters, e.g. performance, software versions or security.
The overall goal of the service is to build a technical, procedural and strategic framework in accordance with compliance regulations (FDA, GDPR, SOX) to ensure the legal and ethical integrity of the company.