SoftwareCPR

SoftwareCPR ® is a recognized expert consultancy in regulated software validation, risk management, and Part 11 compliance for software used in the Medical Device, Pharmaceutical, and Health IT industries and has provided training internally for regulators such as the US FDA, Taiwan FDA, and Health Canada. It has also led or participated in relevant national and international standards development. Auditing, Planning, and Risk Analysis can be provided in addition to hands-on ValidationCPR services. Training and consulting are provided in English, Chinese, Spanish, and Italian.