Validation Master Plan

Main Process

 

Contains all validation activities with the respective documentation and planning. The validation master plan is subjected to regulatory inspection.

It is created by the user in order to define validation activities, responsibilities and procedures. The SAP consulting solution Process Validation Content (PVC), regarding the solution manager as the validation framework, delivers additional documentation and templates for the validation master plan.

Prerequisites

• URS
• Validation Policy

Tasks and Content

• Preparation, review, and release of validation master plan
• Roles and responsibilities
• Organizational structure
• GxP criticality assessment
• Validation strategy
• Validation deliverables
• Acceptance criteria
• Change control management
• Standard operating procedures
• Training
• Documentation management
• Maintenance of the validated state

Result

• Released Validation Master Plan

Along a solution's life cycle, major changes to the underlying system landscape can become necessary. Changes of this kind are typically initiated to re-align with changing business strategies (e.g., centralization, divestitures) or to reduce the cost of an environment that has grown ever more complex.

System landscape change consulting addresses all specific needs of an IT-driven landscape change project.

As a trusted advisor, SAP informs you of transition options and facilitates the upgrade procedure through tailored services and specialized tools and technologies.

To fully benefit from the latest technologies and business enhancements, SAP recommends upgrading your existing SAP solutions on a regular basis. Upgrades to the newest SAP software releases are covered by your SAP maintenance agreement. Upgrades should be an integral part of your maintenance plan, and SAP offers upgrade strategy and assessment services to facilitate your upgrade decision process.

SAP has found a solution to one of the most costly and time-intensive implementation tasks: migrating legacy systems. In the past, the costs of data migration have accounted for up to 20 percent of the total cost of an SAP implementation project. This cost has now been dramatically reduced. To do this, SAP offers custom tools that make an efficient migration of data possible.

Tools

• Legacy System Migration Workbench (LSMW)