SmartInspect System

►A real-time ,wearable, wireless, mobile Internet based conferencing system with “feet”, i.e. yours while mobile

► Allows live video transmission while roaming and voice talking (like Skype) between two parties at remote sites, e.g. South Korea and Syracuse or Peapack, NJ and China to collaborate

►Advance features allow snapshot picture taking or entire video/audio session recording; Handheld 40X self-focusing camera allows printed or written SOPs or labels to be read by remote viewers

►Remote users use existing desktop or laptops for collaboration with unlimited software download

►Encryption and VPN support for security within pharmaceutical enterprise IT infrastructure

►Possible Applications: Technology transfer. Remote quality audits, 3rd party manufacturing diagnostics, remote live training at pharmaceutical manufacturing sites

What is it?

Brain Hasselbalch, US FDA, also from Division of Manufacturing and Product Quality, Office of Compliance , stated that :

“US FDA could potentially require drug makers to conduct on-site audits at manufacturing facilities run by outside contractors.”

Director of US FDA, DMPQ (Division of Manufacturing & Product Quality) says:“This technology does sound like it has some promise to help a firm’s external auditors with additional expertise in some cases without being at the audited site”