As a provider of computer system validation services, sofd can help you to conduct your validation processes efficiently. Our certified experts will work with you to plan and supervise all activities necessary for the validation of your computer systems. Our validation documentation is GxP-compliant and fulfills all requirements of the GAMP 5 guidelines.

We work together with our clients to create the necessary specifications, such as validation plan and user requirement specifications. We support our clients in the formal assessment and minimization of risks. In the process, we derive the scope and content of the necessary tests from the risk analysis. We define the necessary tests according to the "V" model of the GAMP 5 guidelines by connecting each to a requirement from the specification document. Our documentation is designed to be appropriate for all validation phases, i.e. Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

We can help you to deploy your resources in an optimal fashion, saving both time and money.