Intended Use Validation (IUV) is used by the US Food and Drug Administration (FDA) to establish documented evidence which provides a high degree of assurance that a specific business system will consistently produce results that meet predetermined specifications and quality attributes. Many IBM clients use Rational DOORS to manage requirements for their products in a highly-regulated and extremely competitive environment.
Rational DOORS must undergo IUV for each new feature and product revision used by research and development teams.
This session will introduce the audience to some of the issues encountered and overcome by clients in validating the DOORS product for their use.
Audience members will take away:
- Understanding of FDA requirements for IUV of Quality Affect software in class 3 medical devices.
- Best practices for creating documented evidence of Intended Use Validation.
- An Introduction to components of the Rational solution for Medical Device Manufacturers