To assure quality and minimize risks, companies must achieve a state of continuous audit compliance or audit readiness. Many companies are finding themselves turning to compliance audit management software for conducting compliance audits to achieve a state of audit compliance.
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Compliance audit management software systems currently on the market usually cater to a specific segment of companies. Moreover, these solutions often focus on conducting a particular type of audit. For example, some compliance audit management software systems focus on management of external audit programs while some may allow companies to conduct internal or customer audit programs. To meet the requirements of all small, medium, or large size companies and accommodate different kinds of audits, MasterControl offers an unmatched compliance audit management software solution.
In order to excel in business, companies must conduct thorough audits on a regular basis. This helps ensure that processes in the system are running as smoothly as possible and producing optimum results. FDA, ISO, and similar regulatory bodies have devised guidelines to instruct companies as they strive to achieve and maintain compliance. Companies can run an audit checklist based on these guidelines to verify the efficiency and effectiveness of internal processes. The MasterControl Audit solution promises compliance audit management for companies of any magnitude. MasterControl Audit is a web-based application that allows auditors, employees, vendors, suppliers, and any other authorized users to contribute to and monitor the audit program.
The first building block of an audit is planning and scheduling. A carefully thought out audit ensures that the overall strategy for testing business processes is adequate. With MasterControl's online platform readily accessible by users from virtually anywhere, management can benefit from useful ideas in planning a sound audit in a timely manner. Because audit-related data goes through several rounds of updates before it is complete, MasterControl Audit guarantees that users have access the most up-to-the-minute version of any document. Documents can also be escalated for speedy approval when necessary. Perhaps most importantly, the system is in complete compliance with FDA 21 CFR Part 11 and ensures that company bases its audit program under FDA and ISO regulations.
For better manageability of audits, MasterControl Audit divides the audit into different stages such as analysis, planning, tracking, execution, etc. This division helps focus each stage on specific business goals and allows auditors to closely monitor audit findings. MasterControl Audit also enables the various groups within an organization to define their own audit categories. Typically, these categories are linked to specific regulatory requirements, which are used to guide (versus control) the Compliance Audit management process. This is industry practice, and enables QA to report or trend in a manner similar to the FDA. The built-in flexibility of the software also makes it easy for auditors to investigate potential problems that were unforeseen. Top level executives can assess risks and develop contingency plans to prevent negative developments in the company's business. Customizable audit finding and tracking forms facilitate the storage of accurate and thorough audit results. The system also enables managers to create additional customized forms as per business requirements.
After audit data is captured, the next step is to gather information from different sources and interpret it in a format understandable to relevant personnel. MasterControl compliance audit management software provides reporting functionality for generating reports such as GLP required Master Schedule and QA Statement and the GCP Compliance Statement that illustrate a clear picture of the business. This allows companies to take appropriate corrective, preventive, and preparatory actions as well as derive plans for business improvements.
This centralized, Web-based compliance audit management software is ideal for companies that don't need to plan and manage their audit resources on a large scale. All they need right now are compliance audits to assure quality and minimize their audit risk. MasterControl Audit is a straightforward solution for compliance audit management that easily meets both of these requirements, and, like MasterControl QAAD, can be seamlessly integrated with other quality solutions in the rest of the MasterControl Quality Suite.
Identifying problems in business is usually not enough for finding the quickest resolution. That's why having an effective compliance audit management solution is only a small part of the picture. What companies really need is a transparent, effectual overall quality management system.
For this reason, MasterControl provides seamless integration of our compliance audit management software solution with other cutting-edge quality solutions such as our document control, change control, CAPA, training, and other solutions in the MasterControl quality management suite.
For more information about compliance audits or compliance audit management software, please feel free to contact a MasterControl representative