Sarasota, FL, 23rd October 2017 –  Generis is pleased to announce the release of the updated CARA preconfigured module for Quality / SOP / GxP documentation, based on the DIA Reference Model.  CARA is the innovative and leading user interface for Documentum providing easy and fast user functionality, together with a comprehensive configuration toolbox.

The module is a preconfigured package of the standard CARA product to provide functionality required for managing all kinds of Quality Management (including SOP) documentation. This package covers all the standard features required such as:

  • Template-based creation of documents
  • Document numbering (based on any combination of properties)
  • Viewing Effective versions even when more recent Draft versions exists
  • Dynamic Security based on any combination of properties
  • Workflows for Review, Approval, Periodic Review, Making Obsolete etc.
  • Mechanism for superseding previous Effective versions
  • Periodic Review workflows and notifications
  • Automatically make documents Effective on a particular date (e.g. Planned Effective Date)
  • Viewing documents by scanning a QR code (e.g. on iPad in a lab)
  • Change Request mechanism
  • Watermarking depending on status or any other attributes – including different overlays for viewing, printing, exporting and controlled printing
  • Capturing eSignature on user actions and adding eSignature pages
  • Controlled printing including print numbers, reason for printing, print addressee.

Available with this package is also the CARA Portal with dedicated search and viewing for consumers.

James Kelleher, Generis CEO, commented “Our involvement in the DIA group of Life Sciences companies and vendors which defined the Reference Model ensured that we were able to build a module based on 100% compliance.  We have now enhanced it with additional functionality around controlled printing and recall, and portal experiences for light users. Our validation package allows companies to go from selection to implementation in a very short timescale, significantly reducing the cost and complexity of such systems and projects.”