With increasingly complex regulations and expanding globalization, it is not surprising that many life science companies feel overwhelmed when it comes to quality assurance auditing.
MasterControl provides audit quality control via software systems that are designed to effectively and efficiently manage quality assurance auditing.
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Quality assurance auditing is a concept widely used in internal, external, and customer audits for measuring quality assurance within an enterprise. The greatest challenge to effective quality assurance auditing is ensuring that procedures correctly mirror documented standards. Because a single development or research cycle for any manufactured product can result in an abundance of documents and forms, companies establish quality assurance departments to ensure process quality can be maintained. It is also important to regularly audit the quality assurance procedures so that the management can evaluate the efficiency of these procedures.
MasterControl Audit is a complete audit software solution designed to help different types of businesses conduct effective audits while maintaining quality assurance in standard operating procedures.
MasterControl Audit helps companies automate and streamline quality audit processes. MasterControl ensures that customers are able to meet the basic requirement of any audit:to make sure that all audit-related documents are immediately accessible to auditors. The MasterControl quality assurance auditing solution is entirely web-based, which allows users to search and retrieve documents from virtually anywhere. Authorized users (i.e., customers, vendors, employees, auditors, etc.) can collaborate in planning an audit and monitoring ongoing activities during an audit. The exchange of data and ideas through an online platform produces favorable results in conducting a thorough audit that best meets the company's requirements.
Conducting quality assurance audits can be difficult, especially if the audit spans to multiple stages. Manually scheduling audit activities can further complicate the process and often results in accidently overlooking certain tasks in the audit program. The An entire stage of an audit is missed, rendering the outcome of an audit inaccurate. To avoid this situation, MasterControl Audit allows all scheduling tasks to be automated, which eliminates the risk of overlooking a task during audit planning. Auditors can also simultaneously schedule multiple audit programs to be executed without compromising the quality of the audit or having a negative impact on findings.
Quality assurance auditing focuses on complying with regulations and guidelines set forth by regulatory agencies such as ISO and FDA. MasterControl Audit allows companies to centrally organize and securely store documents and forms required by such regulations in a manner that encourages effective quality assurance auditing. Electronically storing all documents in virtual vaults helps to better organize data and information.
With MasterControl, audit findings may also be tracked through advanced tracking forms. This allows auditors to monitor audit results in real-time. The same results serve as the basis for generating various reports that depict the actual state of the business to top level management.
The system can be configured to automatically launch CAPA forms to rectify issues that surface as a result of an audit. Because quality assurance auditing also highlights different risks that threaten the company's business, MasterControl Audit also provides management with the means to prioritize risks according specific business areas and level of impact. Companies are therefore able to better attain and sustain a state of "audit readiness". The solution's transparency assures management oversight and has helped many different types of companies achieve their quality goals.
For more information about quality assurance auditing or other aspects of audit processes, please feel free to contact a MasterControl representative.