Validation

We have more then 20 years experience in Validation of Systems and Equipments

We can support you in creation of all relevant validation documents according to V-model:

· High Level Risk Assessment

· Validation Plan

· User Requirement Specification (URS)

· Functional Specification (FS)

· Design Specification (DS)

· IQ Plan and test scripts

· OQ Plan and test scripts

· PQ Plan and test scripts

· Functional Risk Assessment

· Traceability Matrix

· Validation Report

In addition we can support you in the performance of the corresponding validation steps.

Simplified V-Model view (source: labcompliance)