caralogo

Full end to end GxP Quality Management including
Documentation, Quality Events, CAPA, Change Requests and reporting / traceability

FULL QMS

FULL QMS

Manage Quality Events, CAPA items, Change Requests and Effectiveness Evaluation, all linked directly to documents and other content.

SOP AND OTHER DOCUMENTATION

SOP AND OTHER DOCUMENTATION

Document creation, review, and approval with eSignature, periodic review, and effectiveness, and controlled printing. Video and Augmented Reality content also supported.

TRAINING MANAGEMENT

TRAINING MANAGEMENT

Manage training roles and matrices, capture training on documents (e.g. SOPs), as well as external training, including attachment of training certificates. Report on training status.

E-FORMS

E-FORMS

Create and manage form templates, and allow users to fill in and save instances of the form with data, which can be rendered to PDF for review, approval & archive.

CARA for End-to-End Quality

CARA for Quality Management is an end-to-end configuration package of the standard CARA product to provide the functionality required for managing all kinds of Quality (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, 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.

Uniquely, CARA also provides all the QMS-related functionality such as Quality Event management, CAPA items, Change Requests, and Effectiveness Evaluation, all of which can be directly related to documentation, allowing traceability from documents to QMS information seamlessly.

CARA for Quality also includes Training Management, capturing both training on documentation as well as external training received, with the ability to attach certificates. The Training Management has configuration to set up training matrices for different roles, and track/report on training progress.

Content Management including

  • Content creation (including video format SOPs) including Document numbering
  • Viewing Effective versions even when more recent Draft versions exists
  • 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)
  • Watermarking and eSignature capture and manifestation
  • Controlled printing

QMS functionality including

  • Quality Events definition
  • Risk Assessment
  • Root Cause Analysis
  • CAPA items
  • Change Requests
  • Effectiveness Evaluation

Training Management including

  • Definition of training roles and matrix
  • Capturing document training (e.g. SOP)
  • Capture external training with certificate attachment
  • Track and Report on training progress

eForms including

  • Definition of form templates with picklists, conditional dependencies / visibility / mandatory enforcement, with value assistance from dictionaries or external systems via scripting
  • Creation / completion of form instances
  • Rendering of form instances to PDF for review / approval / archive

General CARA features

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

WIDGETS
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.

VIEW MANAGEMENT
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
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.

USER PREFERENCES
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.

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

Over 400,000 users and growing…

car
CONTACT