Yxion delivers support for:

• Validation
• Documentation
• Registration/Regulatory Affairs
• Clinical Studies

Yxion's validation approach is based on the international ISPE “V-model” for validation of equipment, systems and utilities. Yxion delivers URS, CIA, VMP, Risk Assessments and all validation documents and test plans.

In Yxion’s philosophy, the validation effort should not only focus on the qualification side of the model (IQ/OQ/PQ) but must start with the design and engineering side (Good Engineering Practices and Design Review). With this, compliance of the end result with international guidelines and customer expectations is assured already in the early stages of the project.

Besides that, Yxion’s validation activities are risk based to make sure that only relevant equipment will be validated and waste of time and money to qualify low risk operations is avoided.