CSV for GxP

Case Study: Computer System Validation Example

A real-world example brings CSV to life. Here is how a GxP organization validated a critical system from planning through release.

Scenario

A pharmaceutical company implemented a Laboratory Information Management System (LIMS) to automate sample tracking, test execution, and quality release reporting. The system impacts GMP quality decisions, so it required full CSV aligned to 21 CFR Part 11 and EU Annex 11 .

Validation approach

URS : documented requirements for sample chain of custody, audit trails, and data review workflows.
FS / DS : mapped requirements to configuration settings and integration points with instruments.
IQ : verified deployment on a qualified server environment with controlled access.
OQ : tested audit trails, access controls, error handling, and security roles.
PQ : executed real-world sample workflows with QA sign-off.
RTM : confirmed 100% requirement coverage across test cases.

Outcome

The validation summary report confirmed all requirements were met, deviations were resolved, and the system was released for production use. The company now runs the LIMS under formal change control and periodic review, maintaining a validated state.

Benefits

Improved laboratory efficiency and faster release decisions.
Inspection-ready evidence for both FDA and EU regulators.
Reduced risk of data integrity findings during audits.

Ready for a similar outcome?

We help teams execute validation efficiently, with documentation and testing aligned to risk. Explore our CSV services or talk to us about your system.

View CSV services Request a consultation