Regulated companies are responsible for ensuring quality compliance audit management software systems as well as compliance to regulatory requirements. In order to accommodate both, MasterControl presents Compliance Audit Management Software Systems that facilitate compliance with FDA regulations and ensure that quality is maintained throughout the company.
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MasterControl Audit is a complete compliance audit management software system that eliminates difficulties faced by companies during audit processes. No matter the size of the company, MasterControl Audit is equipped to handle and manage audits round-the-clock without slippage or miscalculation. Depending on the nature of the business, different types of audits are necessary such as internal, customer, and compliance audits. For companies doing business in regulatory environments, the primary aim is to attain compliance with FDA, GXP, and ISO regulations. After compliance is initially achieved, the company strives to sustain compliance in processes. This is where MasterControl’s compliance audit management software system has an edge on its competitors by incorporating quality in audit programs. Every aspect of business is carefully audited to ensure maximum output.
In order to ensure quality in the system, it is necessary to run frequent audits. Large companies with multiple auditors or audit teams may find it difficult to bring quality to the forefront when there are multiple business areas requiring attention. In paper-based or hybrid systems, the focus on quality is overlooked as the majority of paperwork has to be handled manually. This is the biggest problem and a serious cause of non-conformity when different departments access multiple or outdated versions of documents while executing a standard operating procedure (SOP).
MasterControl’s compliance audit management software system provides a centralized repository that is web-based and readily accessible by any authorized user across the globe. All audit-related data and the documentation structure are managed online in a secure location.. Instead of going in circles to find and retrieve documents, auditors can perform easy searches and readily find the documents they need. In addition, the electronic task assignment and follow-up features makes it relatively simple to assign tasks to team members. This allows for the tracking of critical tasks and the escalation of tasks to concerned personnel if they are not completed within the deadline.
Scheduling audits can be a cumbersome task, especially when there are multiple audits that require scheduling and planning in the compliance audit management software system. As many audits may be executed simultaneously, it is up to the auditors to properly schedule and monitor audits. As an audit helps evaluate efficiency of processes in the system, it is likely that the audit itself can be complex in nature. This is the reason MasterControl Audit splits every audit into different stages. Segregation helps focus on each aspect and ensures that the steps involved in an audit are properly executed. Moreover, companies can automate the scheduling of audits as per business requirements. This prevents personnel from overlooking any task vital to the audit.
MasterControl Audit 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 audit process. This is industry practice, and enables QA to report/trend in a manner similar to the FDA. The built-in flexibility in MasterControl’s compliance audit management software system also makes it easy for auditors to investigate potential problems that were unforeseen.
With audits, companies can analyze their strengths and weaknesses. Disparate tools such as flowcharts and spreadsheets are inadequate in presenting a clearer overall perspective of the business. This is where MasterControl compliance audit management software system allows users to generate reports that are accurate, up to date, and bring important statistics to light. MasterControl Audit provides several reports that outline different aspects of the business such as the GLP-required Master Schedule and QA Statement, and the GCP Compliance Statement. Another benefit of MasterControl is the availability of flexible CAPA functionality. If any process evaluation presents issues, management can launch a CAPA process within the audit to fix the problem. This allows zero tolerance for occurrence of future errors. Eventually, the company can predict, mitigate, and manage risks within the audit management software system.
For more information about audit compliance or compliance audit management software systems, please feel free to contact a MasterControl representative