Computer system validation (CSV) and Computer Software Assurance (CSA)

Validation must not be paperwork for its own sake. LBP validates your systems as the lab uses them in practice — risk-based per GAMP 5 and the CSA approach: more evidence where product quality or patient safety is at stake, less where risk is low.

• Scope and risk classification
• Validation strategy, test protocols and deviation handling
• Link to change control and data integrity
• After go-live, Stay validated keeps the system in a validated state.

See also digitalisation and AI & smart systems.