Validacion

System Validation

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Available Resources

GAMP5 Draws Near

Risk Assessment Model (RA)

Systems of Clinical Investigations

System Validation



Our team of professional experts in System Validation receives continuous training in order to provide the highest quality service to our clients. All our validations are conducted according to the current GAMP and the specific international policies of your company.



Which are our products?

Validation Master Plan (VMP)
Migration Plan


Our products

User Requirements Specification (URS)
Protocol Writing and Execution (DQ, IQ, OQ, PQ)
Suppliers Analysis and Auditing
FAT and SAT Writing and Execution
Risk Assessment (RA)
Change Control follow up
Traceability Matrix
Deviations follow up and Closing
Configuration Plan
Revalidations
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