Audit Management
Understanding how to conduct a thorough quality audit is an essential control measure for any organization. Unfortunately, many organizations do not have the luxury of hiring well-seasoned professional auditors-- they must develop them from within.
Our Audit Management solutions show you how to thoroughly manage a quality audit, sharing insight into pertinent regulatory requirements, as well as the necessary planning, performance and post-audit remediation techniques.
We provide training for internal auditors to perform internal or supplier audits. We also provide external auditing support, including coming on-site to perform a second party audit.
PathWise focuses on a solution-based approach to solving client issues. When audit training is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.
Organizations who conduct their own internal quality audits often lack the necessary resources, time and qualified team members to manage the audit appropriately. Our consultants provide an outside perspective to quality audits and can help identify risks and issues within the quality system.
Why do we need quality audits?
A quality audit is a documented independent inspection and review of a quality system, performed on a periodic basis in accordance with written procedures. The objective of a quality audit is to verify, by examination and evaluation of objective evidence, the actual degree of compliance with those elements of the quality system under review. These audits are an essential part of manufacturer's effort to assure safe and effective products. Regardless of how well a quality system is planned, monitoring of the system is required if the quality system program is to be effective in assuring that finished products meet specifications.
Without an effective quality audit function, the quality system program is incomplete -- there is no assurance that a manufacturer is consistently in a state-of-control. Without an audit, the quality system becomes an open loop without feedback to management and without corrective action. Without management support, the quality system program will eventually become ineffective and, as history has shown, ignored.
* Source FDA.gov
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