• 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

• 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

• 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

• 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

Pharma sites • Prepare Leading Big Pharma PGM Sites for FDA inspection readiness • Real time gap analysis on potential critical audit observations • Build partnerships with Emerging Market sites to leverage Leading Big Pharma

expertise to assist in their ability to comply with US, EU and Leading Big Pharma standards.

• Protect Leading Big Pharma Supply Chain

SmartInspect Capabilities for Pharmaceutical SmartInspect Capabilities for Pharmaceutical GMP Supply Chain & Tech TransferGMP Supply Chain & Tech Transfer

• 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

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.”

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”

http://fdasmart.com/smartinspect/remotediagnostics.html

http://fdasmart.com/smartinspect/remoteinspections.html

US Office Address: 7 Barlow Court, Amawalk, New York 10501 - USAINDIA 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