The template systematized validation documentation. The template was consistent with corporate and industry standards. Specific categories on the template were as follows:

• Validation project description, including reason for project and justification for project. Project justification described considerations for acceptable project completion as follows:

o Policies governing change
o Impact of change
o Documents requiring changes
o Regulatory implications
o Notification of affected organizational areas

• Technical basis for project
• Validation strategy
• Validation documents required to accomplish project
• Reference documents supporting project

Results: The facility validation documents with enhancements were maintained.

Customer benefit: There were two significant customer benefits in this project:

1. Validation document maintenance. Validation documents were maintained as required by the original project scope.

2. Validation document enhancements. The enhancements to the validation documents significantly improved the validation documents. Validation documents became a resource to the organization.

Summary: The contributions of Chicago Controls enabled successful project completion and exceeded customer expectations.