• 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
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Remote users use existing desktop or laptops for collaboration with unlimited software download Encryption and VPN support for security within pharmaceutical.
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• 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”