MasterControl Audit Overview

MasterControl Audit is a separately-licensed module that enables a company to manage an audit process in both group and individual applications.  Companies perform audits to ensure and verify that various entities (process, system, site, supplier, department, study, etc.) are operating in accordance with the applicable standard(s). These audits are an integral part of a company’s overall risk management system.  Auditors have the capability to create and present a professional final audit report with minimal effort. Additionally, it ensures that the appropriate follow-up takes place by managing all the associated activities that audits initiate so that companies can stay in compliance with regulations as well as improve their business processes.

The Audit module allows users to:

• plan and schedule audits, with allowances made for predetermined holidays.

• execute audits.

• capture findings offline.

• manage the associated findings, responses, and CAPAs.

• report on the resulting data, including the creation of rich text final audit reports.

The Audit scheduled task runs automatically on the first day of each month and creates another month of the Audit Schedule with the applicable Audit Entities with their Audit InfoCard Types and frequencies (see Viewing the Audit Schedule).

It is also possible to create ad hoc audits that only run once.  See Creating an Audit InfoCard for more information.

For more information on the rights associated with the Audit module, see MasterControl Audit Rights.