is the developer of AcQualis™, a CAPA
(Corrective and Preventive Action) Application for medical device
Although more recently commercialized, this is a highly mature
application in daily real-world operation for more than nine years. Its
unique collaborative features have been instrumental in raising the level
of participation and the quality of documentation for teams resolving CAPA
issues and related actions.
The design of this system grows out of an understanding
of the special role played by CAPA in medical device risk management and
seeks to extend and enrich the use of CAPA throughout the organization.
focused on creating the most productive environment possible for
marshaling the skills, observations and knowledge of multiple