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Computer System
Computer System
Validation (CSV)
Robust processes. Reliable systems.
Compliant operations.
We validate your computerized systems
to ensure they are fit for purpose, operate
as intended and meet FDA and GxP requirements.
- IQInstallation
QualificationInstallation QualificationDocumented proof that the system is installed correctly and matches its specification: hardware, software, configuration and environment. - OQOperational
QualificationOperational QualificationTesting that the system operates as intended across its full range of operating conditions, including functions, alarms and security controls. - PQPerformance
QualificationPerformance QualificationConfirms the system performs consistently in real-world use, with actual users, processes and data, and meets its intended-use requirements.