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What are digital signatures?
Digital signatures (standard electronic signatures) take the concept of
traditional paper-based signing and turn it into an electronic
"fingerprint.” This "fingerprint,” or coded message, is unique to both
the document and the signer and binds both of them together.
The
digital signature ensures the authenticity of the signer. Any changes
made to the document after it is signed invalidate the signature,
thereby protecting against signature forgery and information tampering.
Digital signatures help organizations sustain signer authenticity,
accountability, data integrity and non-repudiation of electronic
documents and forms.
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Typical uses of Digital Signatures in the Life Sciences
» R&D
» Clinical Development
» Regulatory Affairs
» Manufacturing
» Marketing, Sales, etc.
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Digital Signatures and Compliance with Life Science Industry Regulations
Digital signatures allow for full compliance with the FDA's 21 CFR Part 11, and help achieve GxP and Computer System Validation. Digital signatures also help organizations satisfy internal SOPs, and and future industry standards such as SAFE Bio-Pharma™.
FDA's 21 CFR Part 11
CFR Part 11 addresses electronic signatures as a form of control for software and systems involved in business operations and product development in the pharmaceutical, medical, biotech, biologics, and other FDA-regulated industries. Part 11 calls for the use of electronic signatures when closed systems are being utilized. However, the regulation specifies that open systems require controls that guarantee authenticity, integrity and confidentiality of electronic records. It goes on to establish that digital signatures are a sufficient method for satisfying the regulation.
To read more about how CoSign enables compliance with the FDA's 21 CFR Part 11, click here.
To read a white paper on digital signature compliance, click here.
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What is CoSign?
CoSign digital signatures makes it easy to digitally sign documents and drawings by
embedding the standard signature technology directly into mainstream
business applications. CoSign produces a signature record for every
signature it captures. This Portable Signature Format (CoSign PSF™)
allows anyone to seamlessly verify and retain proof of identity,
intent, and document integrity without costly, complicated, or
proprietary software. CoSign keeps your business running smoothly by
fully automating and quickly scaling processes at a low cost and with
proper controls.
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CoSign Business Benefits for Life Science Organizations
Accelerated Business. CoSign accelerates the pace of doing business
electronically with customers, partners, and prospects by sharing
quick, easy, and secure transactions and records between firms and
across geographies. CoSign is convenient and handles high-volume
transactions for any size business with ease. The CoSign PSF is based
on industry standards and boasts technical compatibility with a broad
set of applications to guarantee electronic signature records can be
easily read and verified for decades.
Lower Costs. CoSign allows users to reduce costs associated with
authorizing and signing documentation. It also reduces the costs and
quality challenges associated with archiving, audits, and legal
requirements. By reducing costs associated with traditional paper-based
processes (i.e., paper, printing, ink, scanning, faxing, postage, and
processing time), organizations realize a quick Return on Investment
(ROI).
A Simple Click. CoSign makes it easy to sign, verify, and retain
digital records because the digital signature standard is already built
into applications like Microsoft® Word, Excel®, SharePoint®, Outlook®,
Adobe® Reader®, Acrobat®, AutoCAD®, IBM Lotus®, Oracle UCM, and Lawson
M3, among others. Because of this, CoSign users simply sign with one
click using familiar applications.
No Vendor Lock-In. By using a standards-based digital signature
technology, CoSign digital signatures transform signed documents into
portable electronic records that are maintained in a non-proprietary
format. This allows third-party document recipients to easily verify
signatures in commonly used applications without costly, complicated,
or proprietary software.
Document Integrity. CoSign seals documents digitally, verifying the
document has not been altered after signing, providing proof of the
signer's identity, intent, and document integrity over the life of the
document record.
Legal and Regulatory Compliance. CoSign digital signatures enable
organizations to comply with regulations worldwide, including: FDA
Title 21 CFR Part 11, HIPAA, US E-Sign (Electronic Signatures in Global
and National Commerce Act), EU Directive for Electronic Signatures, and
the EU’s VAT Directive.
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CoSign Features
Graphical signatures
- Before the document is sealed, CoSign will add the user’s graphical
signature (wet-signature). This enables a smooth transition from
“rational” signatures to an electronic system.
Multiple signatures - Allows for multiple digital signatures on the same document.
Batch (bulk) signing
–With high throughput, CoSign can digitally sign millions of documents;
making it an ideal solution for bulk signing needs such as eInvoicing
& eArchiving.
Extensive 3rd party application support – Works with many standard applications including Microsoft Word, Excel, Adobe Acrobat and many more.
Sign any document type
– Using OmniSign you can add digital signatures to any document type;
even a proprietary format. OmniSign will convert any document into a
signed PDF file.
Synchronizes with standard user management systems – The CoSign digital signature solution will work within your existing infrastructure, and is easy to use and manage.
Scalability – Scalable from a few signers to several million users, and will work in your existing authentication environment.
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