SureArchiving – On-demand Content Archiving for Offline Storage, Viewing and Exchange

The SureArchiving service provided within the SureClinical platform enables the export of selected documents and record content to offline storage media for long-term archiving.  Typically clinical trial data must be accessible over a long term such as 10 or more years. However, archiving records from most online or cloud enterprise content management applications for storage on offline media can be a challenging process. The SureArchiving module simplifies archiving by capturing clinical trial regulatory documents, related metadata and records and reports, making them all available offline in standards based formats to ensure access over the long term.

SureClinical eTMF documents can be exported to standard PDF/A format which is the preferred archive format used by many US and Worldwide government agencies. Record content is exported to XML and HTML. SureArchiving supports archive viewing using the SureClinical rich desktop client, through any major web browser in offline mode, as well as in Adobe Acrobat or Adobe Reader.

Archive encryption enables sharing of archives with other groups or organizations. Encryption of exported archives is available for all exported content to ensure compliance with HIPAA and other regulatory compliance laws requiring data security and privacy.

Ensure Archive Integrity with Certified Archives™

In order to ensure long term archive integrity and reliability, the SureArchiving service can export documents and records as digitally signed Certified Archives™. A certified archive is a collection of PDF documents and clinical trial metadata records that are digitally signed by the originator.    The certified archive can be viewed by any third party recipient in offline mode via the SureClinical Viewer or in Adobe Acrobat or Adobe Reader.  When the recipient opens a digitally signed archive,  all documents are tested for integrity to determine if they have been modified since creation.  If the certified archive has not been modified after creation, then archive viewers are displayed a blue ribbon showing ‘Certified by’ along with the archive author’s name, providing assurance to the viewer that the archive has not been tampered with.  The archive author’s identity can be verified by the viewer through a third party certificate authority, similar to how an SSL certificate is used to verify the identity of a website.

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Export Content Repositories for offline storage and viewing

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Benefits

  • Preserve important clinical trial records from the SureTrial content repository
  • Minimize risk of loss of critical clinical trial records
  • Minimize paper storage costs by using an all-electronic format
  • Ensure long-term archive integrity
  • Ensure long-term archive reliability

Features

  • On-demand creation of secure archives from cloud documents and records to offline media such as DVD
  • Create a digitally-signed Certified Archive™ which ensures archive integrity, reliability
  • Integrated trust verification feature lets recipients instantly verify who created the archive
  • Encryption of archives is FDA and HIPAA compliant and ensures security when sharing archives
  • Export wizard enables bulk save and export of archived documents to PDF/A format
  • Export to native .SAVE format, Certified Archive™ format (compatible with Adobe PDF format), HTML format (.ZIP)
  • View archives in SureViewer™, Adobe Acrobat or Reader, or Web browser.

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