FDA Part 11 Digital Signing for Health Sciences
Why use digital certificate signing – Digital signing with web forms and surveys have been proven to deliver up to 90% time savings over manual paper signing processes, with higher quality and an immediate return on investment.
SureEsign is the first FDA Part 11 compliance validated cloud signing solution to deliver features that other signing services can’t provide in the highly regulated area of health care and life science digital signing:
Multiple dynamic trust levels, from clinical to commercial document signing, select the signing Trust Level for signing parties. SureEsign lets you dynamically select three trust levels, from Basic Trust to High Trust with government photo ID required for signing
Web Forms enables flexible form data capture from mobile and web, with autoconversion to Adobe PDF and digital signing (optional)
Web Surveys enables flexible survey data capture from mobile and web, with autoconversion to Adobe PDF and digital signing (optional)
Sign Anywhere – from mobile, web, desktop
Trust Certificate™ – Identify all signing parties with a SureEsign Trust Certificate™. Easily view and inspect signing party identity details with our TrustChain™ audit trail in Adobe Reader.
Off the shelf compliance validation for FDA 21 CFR Part 11, EU Annex 11 and HIPAA
Deploying trusted signing in healthcare and life sciences has never been easier, faster and more cost effective than with SureEsign.
Trusted Digital Signing for Healthcare and Life Sciences
SureEsign® is a cloud-based FDA Part 11 compliant digital signing service. SureEsign provides verifiable digital signatures on any office document, including PDFs and 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 that meet rigorous US and EU government security standards.
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. Four trust levels of document signing are dynamically available, ranging from Basic Trust to High Trust with government photo ID. For example, High Trust signing is offered for DEA controlled substance prescription signing. With SureEsign, trusted signing can be completed for one or hundreds of signing party recipients, using mobile, web or desktop devices via our FDA 21 CFR Part 11, EU Annex 11 and HIPAA compliant cloud signing service.
As compared to other signing platforms for healthcare and life sciences, SureEsign provides:
No fee for external signing parties
Multi-recipient bulk send
Enterprise application connectors for Microsoft Office 365 cloud and other cloud and on-premise systems (optional)
Application Programming Interface (optional)
- Independent Compliance Validation Certificate at no charge
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. Adobe digital signing certificates are recognized globally.
External Signing for Vendors, Partners, Clinical Sites or External Organizations is available with SureEsign – No purchase of a signing account is needed With our SureEsign Enterprise Edition, signing recipients don’t pay anything. In contrast, some Part 11 signing services require that all signers purchase a signing account or pay a hefty signing transaction fee. SureEsign external signing parties don’t pay a signing transaction fee, and they don’t need to purchase a signing account.
With other Part 11 signing services, external signing capabilities may be limited: For example, bulk document send of one document to many signers is not allowed; web forms, web surveys with digital signing may be unavailable for use in healthcare and life sciences where FDA Part 11 compliance is mandated.
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. With SureEsign, your organization will save on signing fees since there is no additional charge for external signing parties to complete signing transactions.
SureEsign is included with all SureClinical applications, along with a library of predefined, flexible workflow processes such as Review and Sign; Review, Approve and Sign; Complete Web Form and Sign, and more. These wizard based signing processes simplify and automate healthcare and life sciences document completion and signing for partners, vendors, clinics and patients globally.
Meets US Federal Security Standards – SureEsign with Adobe Certificates meets rigorous NIST FIPS-140-2 level 3 US Federal security standards, and can be used for DEA controlled substance prescription signing. SureEsign is currently used by thousands of signers in life sciences to automate document completion and signing and processes, to reduce paper usage and handling, and to reduce labor costs related to document signing.
REST API Cloud Service – SureEsign is available as a REST API with a library of flexible signing, approval, web form and web survey processes.
Enterprise Application Connectors from SureEsign cloud to popular applications and document storage cloud or on premise systems are available for an additional fee.
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.
Security – Meets Government Security Standards SureEsign with Adobe Certificates meets rigorous NIST FIPS-140-2 level 3 US Federal security standards, and can be used for DEA controlled substance prescription signing (optional fees may apply for High Trust prescription signers). SureEsign is currently used by thousands of signers in life sciences to automate document completion and signing and processes, to reduce paper usage and handling, and to reduce labor costs related to document signing.
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.