Risk Based Validation SOP

SOP System Risk-Based Validation

$75.00

This System Risk-Based Validation SOP defines the procedures to leverage system quality risk criticality and complexity factors in developing a validation approach for Information Technology systems used in regulated activities.

Topics include criticality and complexity assessments, the impact of vendor assessment results, validation approaches, and alternate validation documentation approaches.

A form for documentation of system function criticality, complexity, and validation approach is included with this SOP.