GAMP 5 - Good Automated Manufacturing Practice O1: Appendix O1 Handover

Regulated companies demonstrate the formal acceptance of a computerized system after validation and the controlled transfer into operational use, with responsibilities for maintaining the validated state and data integrity passing to the owners of the process, the data and the system. The project management approach includes a handover process that confirms the validated state with change controls closed, the validation report approved, specifications as built against the configuration baseline, use and support procedures available, business readiness with updated SOPs and training, application components and configuration archived and included with data and metadata in backup schedules; manages open items such as defects, known issues, incomplete training and unapproved documents through incident, change, CAPA or deviation records assigned to the accountable organization with attention to GxP-impacting items; confirms data migration is complete per its plan and report; updates configuration items, the inventory and the configuration management database; establishes service level, quality and operational agreements, operational support procedures and service management tools; transfers knowledge including documentation, records, implicit knowledge and lessons learned; and defines hypercare with transition criteria such as diminishing incidents and demonstrated support knowledge, the period set before go-live and extended for complex systems until business users can operate the solution. Transfers between quality management systems are controlled and communicated, handover may be planned in project, handover or service transition plans and tools, a post-handover monitoring period and rollback strategy are defined, the project manager prepares the system and the process, data and system owners accept it, and responsibility for outstanding actions is agreed.