Computer validations
The validation of computer systems has been for years one of the most important tools that the Pharmaceutical Industry has to demonstrate to the health authorities, the reliability and control status of all its systems.
It is also a constant concern for all pharmacy professionals, who have only user knowledge of the systems and are not IT or management experts.
For this reason, GOMETRICS has an experienced team that can perform the following computer validations:
Computer validations we perform
- Validation of computer systems 21 CFR part 11 (ERES), GAMP5
- Validation Plan (VP)
- Advice on URS drafting
- Risk management documents (RA)
- Drafting and implementation of IQ, OQ, PQ protocols
- Final validation report
