ISO 9001, 13485, and a host of additional globally accepted standards recommend a process audit management approach for conducting audits. The FDA and other governmental organizations also prefer a process audit management approach. MasterControl, Inc. and its leading quality management system (QMS) automates and streamlines audit processes and all other essential quality activities including change control, process audit management, complaints, nonconformance events, CAPAs, and more.
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In any successful business, operations are run by employees who are proficient in their own specific areas of expertise. In order to continually gauge the performance of employee activities and business processes, many companies rely on process audit management software currently available on the market. However, the majority of the available software applications lack the capability to empower management to conduct customizable audit programs in which stakeholders can actively participate.
Quality audit programs are typically conducted by the quality assurance and quality control departments of an organization. These departments are actively involved in planning and scheduling audit programs around a recurring schedule. Process audit management software segments an audit into different stages so that management can break down each aspect of the audit into its individual components. With an effective system, findings captured during an audit should be maintained through customizable forms. The same audit data can then interpreted and used in generating different types of beneficial reports according to organizational requirements.
MasterControl Audit is a centralized process audit management software solution designed to allow auditors, vendors, employees, and different users across the globe to contribute in the audit program from virtually anywhere. This allows users to communicate about and make changes to quality events across departments. MasterControl's process audit management software provides the features necessary to automate process audit management from start to finish. The solution is web-based, centralized, and secure. It provides audit tracking and reporting capabilities and also automates task assignments and audit follow-ups.
In legacy systems, performing simple functions such as searching and retrieving audit documentation can be a tiresome, error-prone task. However, with MasterControl Audit auditors can continue their audit programs by readily accessing all audit documentation under one centralized console. The web-based platform serves as a common ground for storing updated audit documentation at all times. With MasterControl Audit, the system automatically manages messaging, report responses, email messages, email notifications, and the prioritization of process audit management findings.
The entire audit management process is designed to adhere to the guidelines set by regulatory authorities such as the FDA and ISO. Consequently, companies can always be assured of both attaining and maintaining compliance. MasterControl not only automates audit processes, but it also streamlines audits with built-in triggers and launching. In the instance of a non-conformance, for example, a CAPA form can be automatically launched which ensures the elimination of any reoccurrence of the event. The process audit management features of the MasterControl solution is directly linked with the system's risk assessment capabilities, which helps in identifying and prioritizing risks as well as in monitoring, managing, and altogether eliminating risks. The Audit solution can also be integrated with other MasterControl products to monitor activity workflows, identify root causes, and simplify processes with templates.
It is also very useful for automatically launching system messages, reporting responses, emailing messages, sending notifications, and prioritizing process audit management findings.
For more information about MasterControl's process audit management software solutions for internal audit and external audit management, please feel free to contact a MasterControl representative.