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In the Life Sciences industry
electronic collaboration consists of reams of documentation, typically
500,000 to over 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 solution consists of the following components:
- Document management - e.g. Open Text, Documentum, Hummingbird
- Server-side trust integrator - the Kyberpass Life Sciences TrustPlatform
- Client-side software & credentials - signing plug-ins, Secure
PDF Plug-in, Smart Cards, tokens
- Trust infrastructure & digital certificates - as available from
the Identrus banks, and other trusted third parties (TTPs)
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Hardware security
module (HSM) - e.g. nCipher
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Authentication, authorization,
and accounting (AAA) - e.g. Oblix, Netegrity
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Enrollment & provisioning
- through trusted third party (TTP)
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 New Drug Applications (NDAs).
To receive a copy of our Kyberpass 21 CFR Part 11 Technical White Paper, please click here to complete a request form.
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