| Record Type | Document |
|---|---|
| Policy | Change Management Policy |
| Procedures | Change Management Procedure |
| Work Instructions | Production Infrastructure Management WI Product Change Requests WI Business System Change Management WI IT Change Management WI AMI Configuration Management WI |
Change Management is governed by the Change Management Policy and Change Management Procedure. The procedure governs a variety of change types from changes to Veeva software solutions, changes to internal business systems, changes to customer projects, as well IT related changes. A change management program is an integral part of the quality management system, which is intended to demonstrate that changes to Veeva products, critical business systems, and associated infrastructure are maintained in a state of control. Change management includes configuration management and change control. Implemented during the product lifecycle, the change management process ensures that changes to code are evaluated for impact, are controlled throughout the product lifecycle, and released to production in a planned and predictable manner. The change control program is designed to ensure that GxP production systems (i.e., Veeva software solutions) are maintained in a validated state upon changes to software and hardware configuration items (CIs). In addition, Veeva applies change control to critical business systems that support key process areas.
Changes to GxP production systems (both customer software solutions and critical business systems) follow a documented change program, which includes clear scope definition, assessment of impact both technical and regulatory, requisite approvals prior to implementation, and testing commensurate with change criticality. Change documentation follows standard operating procedures and corresponding quality records are maintained in the validated EDMS.