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Audit Management
 Audit management is one of several quality processes that is included in the Quality Management module. An out-of-the-box audit form is provided, however many companies prefer to recreate their existing audit form using Quality Manager’s configurable forms tool.
Moving to an electronic system provides a centralized repository for all audit documentation that makes search and retrieval easy. It provides advanced tracking capability every step of the way, from scheduling and planning to execution to completion. Since it is part of the Quality Manager module, it can be integrated with CAPAs, investigations, nonconformance, or any other quality process. The processes are connected within the system and reports and/or trend alerts can be set so managers are never out of touch with their quality processes.
Forms include information based on the type of audit, date, description, objective, scope, audit area and lead auditor. A coding system is available to help assess the risk of the findings. The task manager ensures proper closure by tracking verification of the response to the finding. Tasks are automatically sent via email to Outlook or other email systems, so users do not need to be logged into the system to be up to date on their workload. Any recurring audit-related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual audit events. Quality Manager automates task assignment and follow-up via automatic e-mail notification. It incorporates escalation capability for any task not completed by deadline.
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Title21 Software’s Audit Events:
• Meets 21 CFR Part 11 requirements with signature manifestation that includes name, date, time, and meaning of electronic signature (reviewed, approved, rejected, etc.)
• Decreases time spent tracking down pieces of information; a central repository allows for easy search and retrieval
• Allows companies to become virtually paperless
• Is part of the Quality Manager Module, so other quality events such as CAPA, deviations, investigations are linked to ensure compliance with FDA regulations and ISO quality standards
• Integrates with the Document Control and Training Modules to create a “Closed Loop” Quality Management Solution
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Some of the reports available include:
Audit Summary: Gives a top-level view of all the audits in the system, categorized by owner and department.
Audit Detail: Detailed view of type of audit, date, description, audit area and lead auditor.
Findings by root cause
Audits by Owner: Lists audits categorized by owner within specific date ranges.
Open Findings: Lists open findings categorized by owners.
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