Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the Session:Learn which documents the FDA expects to audit.How to use the risk-based validation approach to lower costs.How to link requirements, specifications, risk management, and testing. Document a computer system validation project using easy to understand fill-in-the-blank templates.Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA  2006). Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation. Reduce testing by writing test cases that trace to elements of risk management.GlobalCompliancePanelPrice: $225.00Phone: 800-447-9407Fax: 302-288-6884