ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Robustness

The degree to which a software system or component can function correctly in the presence of invalid inputs or stressful environmental conditions.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Software Reliability

Robustness

(ICH Q2 (R1)) The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

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