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FDA Part 11 Digital Signing


Why use digital certificate signing – The FDA has published guidance directives that request the use of digital certificate signing for items such as the FDA 1572 form. Digital signing and web based fillable forms have been proven to deliver up to 90% time savings over manual paper signing processes, with higher quality and an immediate return on investment against labor intensive scanning and costly overnight delivery fees.

SureEsign is the first FDA Part 11 compliance validated cloud signing solution to provide both clinical and commercial users with fully automated trusted digital certificate signing from any popular mobile or web device.  Using patent-pending digital signing technologies designed to authenticate the signing party, SureEsign automates document signing and completion processes, eliminating paper handling and overnight delivery service costs related to signing.  


Trusted Digital Certificate Signing

SureEsign™ is a cloud-based FDA Part 11 compliant digital signing service.  SureEsign provides verifiable digital signatures on any office document including PDF renditions of DICOM medical images.  As compared with simple electronic signatures where an unidentified person scribbles a signature on a tablet or simply types their name to sign, SureEsign uses Adobe digital signing certificates to provide authenticated digital signatures.  

How it works – After a new signer has passed an authentication process, an individually identifiable digital signing certificate is issued and stored in SureClinical’s secure signing cloud.   When a user wishes to sign a document, an FDA compliant multifactor authentication process is utilized for signing.  With SureClinical, trusted signing can be completed for one or hundreds of signing party recipients, using mobile, web or desktop devices via our patent-pending Part 11 compliant cloud signing service.

SureEsign allows multiple digital signatures on a single document. A fully FDA Part 11 compliant signing audit trail log, signature timestamp and signing workflow report is available for all digitally signed documents.

 SureEsign uses FDA Part 11 compliant Adobe digital signing certificates.  The identity and integrity of any SureEsign signed document can be independently verified by opening the signed document in Adobe Reader or in SureClinical’s apps.

SureEsign™ is included with all SureClinical applications, along with a library of predefined sign and review workflow processes.  These wizard based signing processes simplify and automate both clinical trial and commercial document signing.  SureClinical system users (Internal Signers) with SureClinical accounts have unlimited system signing privileges.   

External Signing for Sites, Vendors or External Organizations is available with SurePlatform Enterprise Edition.   Unique in the FDA Part 11 cloud signing market, SureEsign’s Enterprise signing service provides authenticated trusted digital signing by internal AND external organizations globally.  With other Part 11 signing services, external signing may be limited:  For example, bulk document send of one document to many signers is not allowed; and each external signature incurs a signing fee of $8 – $15 per signature, or the external signer must purchase a costly signing service account. Additionally, web fillable and signable forms are typically not supported with other Part 11 signing vendors.

SureEsign Enterprise offers unlimited External Signing for external parties.  SureEsign Enterprise signers with the SureEsign Unlimited Plan can bulk send unlimited documents to an unlimited number of external parties for signing without paying a transaction fee; purchasing a signing account is not required for external signers.

Multi Channel Content Capture

Cost and Time Savings

Accelerate study startup time with digital signing of essential documents from study sites, vendors and external organizations.

Enable higher productivity and accelerate project completion dates with automated Esigning workflows.

Labor cost savings from elimination of manual document scanning, tagging and uploading.

Enhance Document Quality with fully digital document signing and capture and workflows.  Eliminate or reduce illegible scanned documents and manual uploading errors.

Lower risk and enhance compliance with automated document capture and tracking via signing workflow automation.


Global Signing Standards

Say goodbye to manual content capture processes such as wet signing, printing, scanning, uploading, tagging,  naming, and classifying.  Say hello to best in class Adobe digital certificate signing, automated PDF form and document completion workflows with collaborative portals, real-time content capture with automated tagging, proactive content completion notifications, analytic dashboards and more to save you time and enhance quality.

SureEsign’s Adobe Certificate signing  is standards-based, allowing anyone with either Adobe Reader or an ISO 32000 compliant PDF viewing application to verify the integrity of a signed document.   Invalid signatures, revoked signing authority, modified documents and more are flagged in Adobe Reader, providing higher trust, signer authentication services, lower risk from fraudulent documents and higher levels of government agency compliance
to support US and EU EMA digital certificate signing guidance and regulations. 

 Incorporating an integrated FDA compliant digital signature audit trail, multi-factor authentication and an independent x.509 PKI high-trust certificate authority validation path for every signature, SureEsign™ gives you the confidence that your digitally signed documents are signed by the correct party and that they have not been tampered with after signing.  SureEsign™ supports digital signing of essential clinical trial documents or medical images in clinical trials, and can be implemented for any or all members of the clinical trial study team. 

Go Digital today – get time, trust, and quality benefits by implementing Adobe digital certificate signing with SureEsign™ – FDA and EU EMA compliant verifiable digital signatures.



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