FDA Validation 2011 - Reduce COTS Software Validation using the risk-based approach

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.