GxP Risk Assessment For Computerized Systems

By Bobby Bouthillette

There are numerous computer systems used in the life sciences industry. In GxP environments, however, validating and documenting mission-critical systems are required to ensure the integrity of data and audit-readiness. Yet, given the number of systems used, it is unclear which electronic systems require validation and which do not. In our view, a rational, data-driven assessment of a given system helps companies focus their limited resources on validating the right software for GxP environments.

The checklist below provides a framework for evaluating which software should/not be validated. We have taken a numerical approach to help individuals use data in quantifying risk and final decisions.