Product Brochure: Validation Accelerator

The Validation Accelerator with e-Signature for Quality Center provides an efficient means for automating the management of the validation testing process within a regulated environment, and delivers all of the benefits of using Electronic Signatures. The implementation of the Validation Accelerator builds measurable efficiencies into the validation process and streamlines the supporting test activities through automated test management.

The Validation Accelerator includes a services engagement to configure Quality Center for each organization's particular understanding of compliance practices, and to accommodate an organization's particular workflow in support of their specific validation testing process. Validation Accelerator for Quality Center includes:

• Client Specific project template configuration, including workflow and eSignature implementation, validation documentation, and validation services
• Computer System Validation process Integration, including adaptation of tool to existing client validation processes, development of supporting procedures (i.e. QC project implementation procedure), as well as training, maintenance, and support

The Validation Accelerator leverages a comprehensive set of validation documents to accelerate the validation effort, including:

• Validation Master Plan
• Configuration Specification (CS)
• System Requirements Specification (SRS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• SOP checklist
• Traceability Matrix
• Final Validation Report

In addition, Genilogix can provide a turn-key validation project including validation documentation as well as consulting services to execute the validation scripts.