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Remote users use existing desktop or laptops for collaboration with unlimited software
download
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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
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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
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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 audit assistance on Emerging Market Suppliers and Contractors
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Scan in non-english documents for real time interpretation
•
Conduct Mock PAI inspections
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Global Training Resource
•
Leverage EHS, SMEs, QPs and other critical audit team members from Leading Big
Pharma sites
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Prepare Leading Big Pharma PGM Sites for FDA inspection readiness
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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
GMP Supply Chain & Tech Transfer
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Increase consistency on audit findings
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Communicate to PGM sites issues that impact their business
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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
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 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”
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 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.com
Office Phone: +1-516-515-9642
Cell Phone: +1-201-913-0558
Skype: rambalani
Twitter: @RJBalani
LinkedIn: via Inmails or OpenLink
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