FDA has, and with the implementation of the harmonized GMP, will continue to focus in on this area. Lack of appropriate design controls and design validation is a major source of regulatory actions on the part of FDA.
DBT assists your efforts by offering services in the areas of:
- Design and implementation of Design Control Procedures include Product/Process Specification development.
- Relating user requirements to Design Inputs
- Special functions related to design such as cleaning and disinfection for re-usable devices
- Understanding the principles of validation and verification
- Change Control System design and implementation.