GxP / SOP / Quality Management
on Documentum / Alfresco / Oracle WebCenter

DIA EDM Reference Model

DIA EDM Reference Model

Document and metadata set – starting from the reference model

Template-based Approach

Template-based Approach

Create documents, full eTMF structure and add sites, all from templates – all fully configurable

VDoc management

VDoc management

Enhanced virtual documents including concatenation, bulk binding and import / export as ZIP

RIM and Product MDM integrations

RIM and Product MDM integrations

Either use the features in CARA to plan, track, and manage labeling, correspondence, and MDM or integrate with others

CARA for Quality

CARA for SOP / GxP / Quality Management is a configuration package of the standard CARA product to provide the functionality required for managing all kinds of Quality Management (including SOP) documentation. This package covers all the standard document creation, review, approval, signature and publishing functionality required, as well as training (e.g. To Be Read and Understood), reporting and full workflow / lifecycle and Change Request Management, together with Controlled Printing and QR code document viewing. Available with this package is also the CARA Portal with dedicated search and viewing for consumers.

CARA Quality features

  • 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

General CARA features

CARA has a unique ability to allow users to build their own navigation tree view (Dimensions) based on metadata.

Extensible panel showing widgets – choose from core set (e.g. properties, renditions) or create your own, linking in any web service / JSP or query as a widget. Rearrange the widgets pane with drag & drop.

Define different views for different user groups / usage scenarios. Specify different properties, widgets, filters, SnapLists, Dimensions and other options, allowing users to work in the way that best supports their individual processes.

Dashboards provide a strong reporting capability for data both inside CARA and accessible externally via web services, and results can be shown as tables, charts or graphs, exported to Excel.

All settings that users choose to personalize are saved as their preferences, so that the user can login from another machine and will have the same preferences applied.

CARA has a full configuration and customization layer built in to allow faster deployment and easier validation.

Over 400,000 users and growing…