The auditSERVER software application records, in an encrypted file, all software actions that have an effect on the generated or processed data, along with information such as date, time, study number and user login name. This allows you to locate actions that are causing problems and it also discourages fraud attempts.

The application will allow you to meet all fda requirements concerning identification and traceability of actions/modifications done manually or automatically by the software.

Audit-trail files are independent of data files, and can be saved on the local disk or the server.

Special functions allow you to generate audit-trail files:

• when the file reaches a specified size, or 
• at fixed time intervals, or  
• per study, or  
• manually, following a request by an auditSERVER administrator