Digital Signatures for Medical Device Industry

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.

Selected Clients and Customers
Typical Uses of Digital Signatures in the Medical Device Industry
What are Digital Signatures?
What is CoSign?
CoSign Business Benefits for the Medical Device Industry
CoSign Features
Medical Device Industry Regulations & Digital Signatures

Selected Clients and Customers

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Typical Uses of Digital Signatures in the Medical Device Industry

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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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What is CoSign?

CoSign 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 the Medical Device Industry

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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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”.

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