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Genzyme, a Sanofi Company has selected the Comprehensive Audit Trail (CAT) from Xybion Corporation.

What is CAT?

Although Maximo provides the capability for independently capturing these records, a tool such as CAT was needed to be able to provide the user with visibility without the need for custom reports, or support from IT.

CAT (Comprehensive Audit Trail) is an add-on module for IBM Maximo developed by Xybion that provides the capability of displaying the electronic records (EREC) and electronic signatures (ESIG) in a user friendly, easy to view screen.  CAT runs as a tab within your Maximo applications where EREC or ESIG is enabled.CAT displays only the records that have been captured by EREC and ESIG and shows the before and after changes to the user in an easy to view layout.

Genzyme chose CAT based on a number of benefits:

  • CAT provides an out of the box solution, Ease of installation, and Supported Well.
  • No need to create a custom solution either internally or by 3rd party.
  • Validation effort is reduced due to using an out of the box solution.

 

Simple to install and manage

Genzyme, a Sanofi Company has selected the Comprehensive Audit Trail (CAT) from Xybion Corporation. CAT Installs as an additional tab inside of IBM Maximo.  System admins can choose which modules to leverage the additional audit functionality of the Comprehensive Audit Trail.

Request 30 Day Trial Version of CAT v2.0

 

21 CFR Part 11 – What is The Relevant Guidance?

21 CFR Part 11.10e  requires the “Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.”

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