Digital Signatures for the Medical Device Industry

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

Signatures in the medical device industry may be found just about everywhere - from product design, to production and during ongoing servicing -wherever employees need to sign documents. Without digital signatures, these forms have to be printed just so they may be signed, perhaps faxed for approval, and then scanned for archiving purposes. With digital signatures, however, you can complete the signing process with a click of your mouse, without ever having to print the document.

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

CoSign is the best solution
we found to help us create
containerless e-records
ensuring FDA compliance

Marty Sargent,
Aspyra

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Typical Uses for Digital Signatures in the Medical Device Industry

Signatures are pervasive in the medical device industry. From warehouse clerks, field service engineers, production line and up to management, every employee in the medical device industry can easily sign documents using digital signatures.

Some of the many different documents printed for signing purposes in the medical device industry include:

»	ECOs
»	MRB
»	Risk Assessments
»	Deviation Orders
»	Clinical Trial Documents

With digital signatures, you can sign these and any other documents throughout the life cycle of the production of a device in the medical device industry, both legally and efficiently.

Benefits of Digital Signatures for the Medical Device Industry:

Digital signatures can be used for various tasks such as:

»	Product design
»	Work assessments
»	Field servicing
»	Manufacturing
»	Marketing
»	Sales

There is never the need to question the authenticity of records or the identity of the signer.

Digital signatures eliminate the risk of theft and forgery.

You can add both digital and graphical (wet) signatures to a document.

Our digital signatures meet regulatory FDA CFR 21 P art 11 C ompliance.

Medical Device Industry Regulations & Digital Signatures

Digital signatures in the medical device industry enable 21 CFRPart 11 Compliance and achieve GxP, Computer System Validation, internal SOPs, as well as meet new regulations such as SOX and HIPAA.

Learn how digital signatures in the medical device industry enable compliance with FDA and HIPAA regulations.

Digital signatures, such as ARX’s, 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 digital protected information has not been altered or destroyed in an unauthorized manner”.

How ARX Enhances Efficiency in the Medical Device Industry

ARX has created an appliance for digital signatures in the medical device industry, reducing paperwork and increasing protection and security. 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.

Digital signatures ensure 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 and sustain signer authenticity, accountability, data integrity and non-repudiation of documents and transactions.

CoSign is ARX’s appliance that offers a turn-key digital signature, which creates a strong seal for documents & data, ensures compliance with the FDA's 21 CFR Part 11, provides signer authentication and eliminates the need for paper and its related costs.

CoSign Features

»	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 CoSign digital signatures. Contact us today and find out how digital signatures can enhance efficiency in the medical device industry.