Validation Center™

This Standard Operating Procedure (SOP) addresses the FDA requirement that computer systems be validated in a consistent and rigorous manner to ensure quality, reliability, and conformance with regulatory requirements. 

This SOP applies to computerized systems where one or more of the following conditions are met:

• Validation is required to meet quality regulations
• System performance could affect the accuracy or quality of information used to meet specific regulatory requirements
• System performance could affect product quality or patient safety
• System uses electronic signatures.

Topics addressed within this SOP include standard validation deliverables, validation roles and responsibilities, integration of a risk-based approach to validation, and quality assurance controls.