COTS Software Validation – 10 Easy Steps 2012

Key Topics

• How to link requirements, specifications, risk management, and testing
• How to use the risk-based validation approach to lower costs
• Reduce testing by writing test cases that trace to elements of risk management
• Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
• Proven techniques that reduce software costs and implementation times
• Learn which documents the FDA expects to audit
• Efficiently create validation documentation
• · Increase corporate productivity and individual workforce member productivity
• Make documentation more manageable and understandable
• Decrease resource requirements
• Use resources effectively to perform effective validation while avoiding doing too much
• Avoid 483s and Warning Letters
• How to implement a computer system to gain maximum productivity

Who should Attend

IT, Users of computer systems, QC, QA, Managers, Laboratory staff and Executives.