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Audit Management and Control
Effectively managing audits is essential to any quality management program. Good audit
management helps to proactively ensure quality by measuring and improving processes,
procedures, and marketed services and products. In addition, supplied products and services can
be audited to ensure quality adherence throughout the entire value chain. Early detection and
prevention through audit activities is the key to lowering product defects, thereby resulting in higher
customer satisfaction.
Audit Process Management and Control
Good audit management programs begin with a clear definition of audit processes and metrics. In
compliance with current regulations, the system should be able to track progress against previous
audit deficiencies and identify potential root causes in a timely manner. Integrated CAPA processes
ensure that corrective actions are implemented in a timely manner to eliminate potential root
causes.
Audit Management Best Practices
Effective audit management requires a combination of people, processes, and technology to achieve
maximum results. Technology-based audit programs are in and of themselves, insufficient. The best
practices summarized below highlight the essential requirements for automated audit management
systems and the required processes and human resource requirements to ensure sustained
compliance and reduce regulatory risk.
1. Obtain top-down management support and commitment. A fundamental requirement
of any compliance initiative that impacts the entire organization is support from senior
management. Top-down support ensures that compliance is treated as a corporate
mandate versus a departmental challenge. It also ensures that resources will be available
as needed to ensure success.
2. Establish clear policies, procedures, and metrics. You cannot measure the
effectiveness of something that is not defined. Audit management programs should
incorporate defined policies, procedures, and metrics as performance benchmarks. These
elements should be reviewed periodically for continuous improvement.
3. Integrate essential quality management processes. To ensure success, an effective
audit management system should automate the entire audit process and include integration
of the following processes:
o Corrective and preventive actions
o Change control
o Non-conformance tracking and management
o Regulatory document/content management
o Custom reporting, analysis and analytics
o Training
o Compliance intelligence dashboard
CAPA is central to all the audit process. Audits may reveal a number of issues
and process deficiencies. The corrective action process insures that these matters
will be identified, tracked, and monitored in a controlled manner.
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