Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs - GlobalCompliancePanel 2013 is a webinar that covers topics such as:
- How to use the risk-based validation approach to lower costs
- Learn which documents the FDA expects to audit
- Document a computer system validation project using easy to understand fill-in-the-blank templates
- How to link requirements, specifications, risk management, and testing
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
- Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
- Reduce testing by writing test cases that trace to elements of risk management
Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs - GlobalCompliancePanel 2013 brings together:
- QA
- IT
- Laboratory Staff
- QC
- GMP, GCP, GLP professionals
- Managers
