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SmartInspect System. What is it?. ► A real-time ,wearable, wireless, mobile Internet based conferencing system with “feet”, i.e. yours while mobile
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SmartInspect System • What is it? ►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 the US FDA Thinks 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” 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.”
Big pharma currently evaluating SmartInspect Astra Zeneca, Wilmington, DE Bristol Myers Squibb, Syracuse * Devens Sanofi-Aventis, Bridgewater, NJ US AID & USP