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Proactive Audit Management – What You Should Know

Introduction

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. Many of the challenges associated with audit management center around open-ended audits and disjointed business processes. A core fundamental best practice for audit management is top-down buy-in from the organizational executive management. This level of institutional support ensures that quality is embedded into the fabric of the organization at every level.

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 on time. Integrated CAPA processes ensure that corrective actions are implemented promptly to eliminate potential root causes.

Audit Management Cycle

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.

  • 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.
    • Corrective and Preventive Actions (CAPA).
    • Change Control
    • Non-conformance tracking and management.
    • Regulatory document / content management
    • Custom reporting, analysis, and analytics
    • Training
    • Compliance Intelligence Dashboard
  • Ensure closed-loop processes. For automated audit management systems, ensure that they are designed to successfully close out all audit processes on time. As obvious as this sounds, the number one reason for regulatory citations in this area is due to ineffective process closure.
  • Avoid “stand-alone” audit management systems. Audit management is an integrated process that requires a blend of several processes and compliance technologies to achieve real compliance.
  • Establish a proactive internal audit schedule. Continuous improvement demands that organizations periodically review internal policies and procedures and apply the necessary corrective and preventive actions to ensure quality. One fundamental preventive action is to perform periodic audits to ensure compliance and operational performance. Corrective action should be applied to all process or production issues revealed during audits to ensure sustained compliance
  • 21 CFR Part 11 compliance. In FDA-regulated companies, Part 11 is a mandatory requirement. Avoid customizing this functionality if possible.
  • Automate enforcement of audit checks and balances. Automated systems should segregate duties so that the responsibility for the audit is distributed among independent organizations. The system should include and support this best practice. Further, the system should support a multi-tiered approval process to ensure multiple levels of review and approval. Approvals should be documented with 21 CFR Part 11-compliant electronic signatures and accessible as documented evidence that audits were carried out with the highest integrity and credibility.
  • Ensure online and offline access and control. Automated audit management systems must be accessible across the extended enterprise. Most point solutions that address audit management are only accessible in the office while the auditor is online. This is impractical and promotes process inefficiencies and redundancies. Good audit management programs should allow offline completion and later synchronization of critical activities.
  • Leverage integrated document/content management technologies. Audit processes inevitably require documented evidence supporting the entire audit event. During the progression of the audit process, auditors may reference controlled documents as well as generate new documentation in support of the audit. To ensure ready access to production documentation and the management and control of audit documentation, a good audit management system should include integrated document management/content management technologies.
  • Built-in audit alerts and notifications.  One of the key reasons for non-compliance is the lack of follow-up. Day-to-day challenges and other business issues change priorities in a very dynamic manner. A well automated audit management system should include built-in alerts to notify management and personnel when pending action is required. These alerts should be coupled with corrective action plan items to ensure follow-up and subsequent closure on time.
CAPA Process

Figure 1 – Integrated Compliance Process Control

Audit Management Software Process

As shown in the figure above, CAPA is central to the audit process. Audits may reveal several issues and process deficiencies. The corrective action process ensures that these matters will be identified, tracked, and monitored in a controlled manner. All audit management systems must ensure compliance with Part 11 and include process support technologies such as reporting, analysis and trending, regulatory document management, and a documented API that supports integration with existing legacy systems such as MRP, ERP, electronic records management, and others.

Establishing a fully integrated, closed-loop system such as depicted in the figure above will ensure the information flow from one process to another. It should be clear that the integration of compliance processes such as the ones shown above will eliminate silos of information and support enterprise compliance management objectives.

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