Manage Change Control

Evaluate, approve, implement, and verify changes to validated computerized systems while maintaining their validated state.

When to Use

• A validated system requires a software upgrade, patch, or configuration change
• Infrastructure changes (server migration, OS upgrade, network change) affect validated systems
• A CAPA or audit finding requires system modification
• Business process changes require system reconfiguration
• Emergency changes need expedited approval and retrospective documentation

Inputs

• Required: Change description (what is changing and why)
• Required: System(s) affected and their current validated state
• Required: Change requestor and business justification
• Optional: Vendor release notes or technical documentation
• Optional: Related CAPA or audit finding references