Validation strategy The validation strategy, and thus the extent of the validation activities, depends ultimately on the maturity and complexity of the computer software component(s) implied in ISPE ...

FDA served as co-chair of the Association for the Advancement of Medical Instrumentation’s (AAMI) AAMI TIR36:2007 (“Validation of software for regulated purposes”), which was revised and ...

The FDA introduced the framework for computer system validation in 1997 with 21 CFR Part 11, then further refined it in its 2002 guidance document (General Principles of Software Validation).