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In the Life Sciences industry electronic collaboration consists
of reams of documentation, typically 500,000 to 1 million pieces
of paper for a single new drug approval. This has placed an undue
burden on businesses and the regulatory agencies as they struggle
to improve processes and reduce costs. It has been estimated that
of the approximately $800 million required to bring a new drug to
market, between 30% and 40% of that cost is related to paperwork.
Clearly, this is an ideal candidate for process re-engineering.
The Kyberpass Life Sciences TrustPlatform helps to solve this dilemma.
It is one part of a whole-product solution that provides an end-to-end
electronic submission, compliant with all aspects of 21 CFR Part
11, including a legally admissible digital signature in place of
the traditional "wet signature. The whole-product consists
of the following components:
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Document management - e.g. Open Text,
Documentum,
Hummingbird
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Server-side trust integrator - the
Kyberpass Life Sciences TrustPlatform
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Client-side software & credentials
- signing plug-ins, PDF crypto plug-ins, smart cards, tokens
- Arcot
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Trust infrastructure & digital
certificates - as available from the Identrus banks
•
Hardware security module (HSM) -
e.g. nCipher
•
Authentication, authorization, and
accounting (AAA) - e.g. Oblix, Netegrity
•
Enrollment & provisioning - through
trusted third party
With this end-to-end solution
in place an electronic submission consists of pressing the SEND
button rather than the PRINT button. The overall
impact on businesses is dramatic. With fully-automated electronic
submissions the time-to-market for new drug applications (NDAs)
is significantly reduced. The savings translate into between $2
million and $3 million per day.
Another valuable feature of this TrustPlatform
architecture is the ability to perform server-side signing of documents
versus client-side signing. While client-side signing might
seem attractive on the surface, it does not provide the control,
oversight, and auditing capabilities of a server-side approach.
By routing all document signing to the corporate signing server,
organizations can better control and manage their submissions process
and centralize control of NDAs. |
