Digital Signatures in the Life Sciences Industries

The move to comply with the FDA's 21 CFR Part 11 by players in the life sciences, pharmaceutical, biological and medical equipment industries, has seen a migration to electronic systems and a concurrent demand for digital signatures.

With the transformation from paper to electronic documents, players in the life sciences, pharmaceutical, biological and medical equipment industries are mandated to use digital signatures by the FDA's 21 CFR Part 11 regulation. By eliminating the requirement to print the paper forms for authorization, life sciences companies can dramatically save operational costs and shorten processing cycle time. This leads to benefits in areas such as paperwork reduction (as documents are signed electronically they no longer have to be printed) and the protection of intellectual property.

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Typical uses for Digital Signatures in Life Sciences
Benefits of Digital Signatures
Regulations & Digital Signatures
What are Digital Signatures?
What is CoSign?
CoSign Features

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Typical Uses for Digital Signatures in Life Sciences

»	R&D
»	Clinical development
»	Regulatory affairs
»	Manufacturing
»	Marketing, sales, and more

Benefits of Digital Signatures for Life Sciences

»	Never have to question the authenticity of records or the identity of the signer
»	Eliminate the risk of data theft and forgery
»	Add both digital and graphical (wet) signatures to a document
»	Meet regulatory compliance such as the FDA's 21 CFR Part 11

Life Sciences Regulations & Digital Signatures

Compliance with 21 CFR Part 11 and achieving GxP, Computer System Validation, internal SOPs, and new regulations such as SOX, HIPAA, or future industry standards such as SAFE Bio-Pharma with proven technology in these applications.

Learn how digital signatures enable compliance with FDA and HIPAA regulations.

Digital signatures based on a mature & proven PKI (Public Key Infrastructure) technology are the best means to protect the integrity of information.

And indeed these regulations require the protection of integrity “to corroborate that electronic protected information has not been altered or destroyed in an unauthorized manner”.

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What are Digital Signatures?

Digital signatures take the concept of traditional paper-based signing and turn it into a digital "fingerprint". This "fingerprint", or coded message, is unique to both the document and the signer.

The digital signature ensures the signer is indeed the originator of the message. Any changes made to the document after it was signed invalidate the signature, thereby protecting against forgery. Digital signatures help organizations comply with regulations such as the FDA's 21 CFR Part 11, sustain signer authenticity, accountability, data integrity and non-repudiation of documents and transactions.

What is CoSign Digital Signature?

CoSign is an appliance that offers turn-key digital signatures, creating a strong seal for documents & data, ensuring compliance with the FDA's 21 CFR Part 11, providing the signer authentication, and eliminating the need for paper and its related costs.

CoSign Digital Signatures Feature:

»	Quick deployment
»	Zero management solution by utilizing a centralized approach to signing, key storage & management (eliminates the need for Smart Cards, USB Tokens etc.)
»	Data-integrity; Non-repudiation; Signer's authentication.
»	Graphical (wet) signatures.
»	Transportability.
»	Out of the box support for Word, Excel, Adobe Acrobat, InfoPath, and more.

Visit our Digital Signatures FAQ section for more information about digital signatures and how they can be used in the life sciences industries. Contact us today and find out how digital signatures can help your business.