CSV is the documented process of ensuring a computerised system used in pharmaceutical operations consistently produces results meeting pre-defined specifications — per GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
HYDRA is the only Saudi Arabia-based CSV provider. Companies currently rely on UAE or international consultants — with HYDRA you get local expertise and SFDA-aligned documentation.
GAMP 5 category assessment
Validation plan and summary report
IQ/OQ/PQ test scripts and execution
21 CFR Part 11 / EU Annex 11 assessment
Data integrity review and audit trail verification
