MasterControl's Automated Audit Management System can dramatically reduce the time and effort involved in preparing for and conducting audits. Almost all types of businesses undergo audit, but it is particularly critical for Life Science and other regulated companies. For these organizations, regular audits are necessary to comply with regulations and to ensure product safety and quality. That is why regulated companies are increasingly using audit management software systems to facilitate all audit-related tasks and activities.
The popularity of audit management software systems and electronic audit management systems stem from the need of regulated companies to comply with quality regulations and standards.
The FDA's regulations, such as 21 CFR 211 for pharmaceutical companies, Quality System Regulation (21 CFR 820) for medical device firms, and 21 CFR 606 for blood establishments all require regular audits. Similarly, audits are expected of general manufacturers that adhere to the ISO 9000 quality standards and medical device firms that follow ISO 13485 standards. Audit management software systems and electronic audit management systems that exist in the market today are generally designed to address those regulations and standards.
Audits must be performed regularly to be effective. MasterControl Audit™ is an electronic audit management system designed to facilitate regular audits by making them faster, easier, and more effective. MasterControl's audit management software integrates the different steps of the audit process-from preparation to completion- to ensure compliance.
Here is an overview of how MasterControl addresses the most common issues associated with the audit process:
Maintaining an effective compliance and audit management system requires connections between multiple systems. For example, knowing what should be audited and how often requires input from risk systems, audit findings may lead to corrective/preventive actions (CAPAs), and maintaining an approved vendor list needs feedback from vendor audits.
MasterControl connects the audit software processes with the rest of the quality system for a holistic approach to quality management. Audit data is integrated with supplier scorecards, risk scores can drive the frequency and type of audits performed, and quality event forms, such as CAPAs or SCARs, can be launched directly from an audit finding, streamlining the process and ensuring issues raised during audits are properly addressed.
Planning and scheduling audits can be deceptively complex. Some audits occur on a regular cycle, but the types of audits (internal, customer, compliance) conducted and their frequency can vary based on a number of factors. Other audits come up on an ad-hoc basis and managing the resources to make sure everything gets done can be a major stumbling block, especially for companies with numerous audits.
Automates planning of all recurring audit management related activities so they won't be overlooked. Scheduling conflicts that result from double-booked auditors or out-of-office events are highlighted for easy resolution. The audit calendar can be searched and filtered to streamline the scheduling process.
It's difficult to generate accurate and timely reports and trends using disparate electronic spreadsheets and paper documents. Without an effective audit reporting tool, managers are unable to see the big picture of their audit management program.
Provides powerful analytics and reporting capabilities, including customizable reports and online charting. Through the reports, managers get a real-time view of the audit process and can be more proactive about improving the quality system. Our audit management software can easily track issues that are raised during audits and make sure that they are resolved.
For more information about audit management software systems or the solutions from MasterControl, please don't hesitate to contact a MasterControl representative.