Services
Computer validation
The main purpose of validation is to produce documentation which verifies that your system is consistently operating as defined in earlier specifications. Needless to say, this requirement applies equally to SAP systems introduced in the pharmaceuticals environment. Our validation method is aligned to the GAMP approach whilst taking account of the particular requirements of a SAP project.
We provide consulting and support throughout the process:
- In the development of Design Qualification, precisely where our support really makes a difference – with complete specifications that can be tested and implemented! This lays the foundation for the subsequent phases of validation.
- In the creation and execution of an Installation Qualification plan for all regulated system environments, including the Solution Manager.
- In the structuring of Operational Qualification, including compilation of the documentation necessary to verify system functionality in compliance with the specifications (DQ).
- In Performance Qualification: following provisional start-up, the most critical processes are documented during production, to the point at which the system is finally released.
For more information on our validation activities for the SAP environment,
please click here.
