Decommission Validated System

Plan and execute the controlled retirement of a validated computerized system while preserving data integrity and meeting regulatory retention requirements.

When to Use

• A validated system is being replaced by a new system
• A system is reaching end-of-life with no replacement (business process eliminated)
• Vendor discontinues support for a validated product
• Consolidation of multiple systems into a single platform
• Regulatory or business changes render a system obsolete

Inputs

• Required: System to be decommissioned (name, version, validation status)
• Required: Data retention requirements by regulation (21 CFR Part 11, GLP, GCP)
• Required: Replacement system (if applicable) and migration scope
• Optional: Current validation documentation package
• Optional: Data volume and format inventory