The definitions of software validation and computer software assurance are shown in Table 1. The first problem is that both refer to software and not system. The definition of Computerized System ...

Think in terms of assurance activities that are scripted (e.g., documented test cases with detailed steps, ... 1 FDA, “Computer Software Assurance for Production and Quality System Software: ...

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).

The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and ...