Reduce COTS software validation using the 10 step risk based approach 2013 is a webinar that covers topics such as:
- Efficiently create validation documentation
- Increase corporate productivity and individual workforce member productivity
- Proven techniques that reduce software costs and implementation times
- Documents the FDA expects to audit
- Make documentation more manageable and understandable
- Decrease resource requirements
- How to implement a computer system to gain maximum productivity
- Avoid 483s and Warning Letters
- How to link requirements, specifications, risk management, and testing
- Use resources effectively to perform effective validation while avoiding doing too much
- Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
- Document a computer system validation project using easy to understand fill-in-the-blank templates
Reduce COTS software validation using the 10 step risk based approach 2013 brings together IT, Computer System users, Managers, QA and Executives.