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SAFE-BioPharma
SAFE-BioPharma

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!!! Overview[1]
The [{$pagename}]® [Digital Identity] and [Signature Standard|Digital Signature] was started by the biopharmaceutical industry to speed its transformation to a fully electronic environment. It is the sole global identity and signature standard serving the needs of the biopharmaceutical industry.
Every SAFE-BioPharma [Digital Identity] is uniquely linked to the subscriber’s proven identity.
Using the SAFE-BioPharma standard...
* provides interoperability with federal agencies, other companies and other industries
* provides a secure, enforceable, and regulatory-compliant way to verify [digital identities|Digital Identity] and to apply [Digital Signature] in electronic transactions. Compliant with EU/EMA requirements for [Digital Signatures].
* greens the pharmaceutical and [HealthCare] industries by eliminating hidden waste associated with paper
* improves business processes
* is 21 [CFR] Part 11 compliant
* meets [United States Department of Commerce] and [EU] SAFE Harbor requirements for protection of [Personal data]
* mitigates [legal], [Regulatory compliance] and other business [risk] associated with electronic transactions[{$pagename}] [digital signatures] are more secure and useful than simple electronic signatures…
* ensure a single, unique identity is tightly bound to the digital signature
* provide document [integrity] – any change in the document invalidates the signature
* include contract-based [legal] [framework] for global [legal] enforceability
* recognized by [FDA] and EMA
* legally enforceable, [Non-Repudiation], instantly auditable
* create a permanent record of the date and time the signature was applied
* valid for the life of the document
* compatible with electronic workflows
!! More Information
There might be more information for this subject on one of the following:
[{ReferringPagesPlugin before='*' after='\n' }]
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* [#1] - [http://www.safe-biopharma.org/|http://www.safe-biopharma.org/overview.htm|target='_blank'] - based on data observed: 2015-08-22
This page (revision-1) was last changed on 29-Nov-2024 16:16 by UnknownAuthorTop