Change Management
It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections.
A look at development and application of a Change Management process to demonstrate control over changes made to computerised systems, to include software, hardware and documentation.
It considers the controls required during the computerised system development phase, and the on-going change control process throughout the system lifetime.
