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

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

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

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  1. SmartInpect 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 but Secure, Encrypted!) 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

  2. Leading Big Pharma - Use Case SmartInspect Capabilities for Pharmaceutical GMP Supply Chain & Tech Transfer Remote audit assistance on Emerging Market Suppliers and Contractors Scan in non-english documents for real time interpretation Conduct Mock PAI inspections Global Training Resource Leverage EHS, SMEs, QPs and other critical audit team members from Leading Big Pharmasites Prepare Leading Big PharmaPGM Sites for FDA inspection readiness Real time gap analysis on potential critical audit observations Build partnerships with Emerging Market sites to leverage Leading Big Pharmaexpertise to assist in their ability to comply with US, EU and Leading Big Pharmastandards. Protect Leading Big PharmaSupply Chain

  3. Benefits to Leading Big Pharma Global Quality • Increase consistency on audit findings • Communicate to PGM sites issues that impact their business • Ability to deliver situational real-life training scenarios • Review the video record, post audit, for clarity & accuracy to enhance audit report content • Enhance Leading Big Pharma PGM sites compliance to cGMPs SmartInspect Benefits

  4. 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” Also from Division of Manufacturing and Product Quality, Office of Compliance says that: “US FDA could potentially require drug makers to conduct on- site audits at manufacturing facilities run by outside contractors.”

  5. Big pharma currently evaluating SmartInspect Astra Zeneca, Wilmington, DE Bristol Myers Squibb, Syracuse * Devens Sanofi-Aventis, Bridgewater, NJ US AID & USP

  6. Click Below to Watch Video of SmartInspect – Remote Diagnostics http://fdasmart.com/smartinspect/remotediagnostics.html And SmartInspect – Remote Inspections http://fdasmart.com/smartinspect/remoteinspections.html

  7. US Office Address: 7 Barlow Court, Amawalk, New York 10501 - USA INDIA Office Address: 2/7, Tagore Park, Nr. Nehrunagar Cross Raod, Ambawadi, Ahmedabad 380015 - Gujarat For more information on SmartInspect or to arrange for a 10-minute DEMO, contact Ram Balani: Email: rbalani@fdasmart.comOffice Phone: +1-516-515-9642Cell Phone: +1-201-913-0558Skype: rambalaniTwitter: @RJBalaniLinkedIn: via Inmails or OpenLink

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