Audit Management Software Systems
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. Regulated companies are increasingly using audit management software systems to facilitate all audit-related tasks and activities. An automated audit management system can dramatically reduce the time and effort involved in preparing for and conducting audits.
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Audit Management Software Systems for Companies in FDA and ISO Environments
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.
How Can MasterControl Audit Management Software Help You?
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:
MasterControl provides professionals with superior tools to conduct and manage the perfect audit. With MasterControl’s unrivaled audit management system, auditors can:Audit Management System Challenges | MasterControl Audit Management Software Systems |
| Disconnected Audit Management Systems 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. | Connected Audit Management Software 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. |
| Inefficient Audit Scheduling 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. | Advance Audit Scheduling 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. |
| Audit Management Results Lack Visibility 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. | Audit Management Software Increases Visibility 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. |
What Sets MasterControl Audit Apart from Other Audit Management Software Solutions?
- Comfortably utilize familiar tools like Microsoft Word and Outlook to conduct audits
- Effortlessly plan and schedule audit management resources using MasterControl’s online drag and drop calendar
- Take delight in easy audit management software report creation thanks to rich text data that is maintained all the way from auditor entry and peer review through to automated report generation
- Enjoy seamless connections that enable stress-free management of CAPAs, suppliers, and risk
Top 5 Benefits of MasterControl Audit Management Software
- Simplifies Auditor's Job:Task-based system allows auditors to easily and efficiently participate in different stages across multiple audits. They can complete their tasks faster and more effectively when companies have readily-available, organized and comprehensive documents
- Reduces Audit Preparation Time and Effort:Planning, scheduling and conducting audits requires much less time and resources. Creating templates for audit memos and announcement letters facilitates fast, consistent and professional communication.
- Instant Access to Important Data:Company executives have immediate access to critical data, which makes it easier to pinpoint the root cause of non-compliance issues. This helps them maintain confidence with audit processes and achieve their continuous improvement and compliance objectives.
- Consolidation of Data:With quality audits, data is commonly interspersed and controlled using a variety of processes and procedures. An automated audit management system enables auditors to consolidate data from disparate tools and other auditors and manage it all from a centralized tool.
- Easy to Implement and Validate:The unique validation approach significantly reduces the time, effort and costs involved with validation.
Top 10 Features of MasterControl Audit Management Software
- Connected Audit Management:Integrate all the steps of the audit process from preparation to completion. Automatically determine what should be audited and how often by integrating with Risk, Supplier, and our new Studies module. Launch quality event forms, such as CAPAs and SCARs, right from the audit findings. Web-based platform allows all employees involved in audits to connect from virtually anywhere. Guest connections provide external responders secure and direct access to the audit.
- Advanced Audit Scheduling:Create a plan of all audit-related activities with an easy-to-use, drag-and-drop audit scheduling calendar. Set up groups to view audits by status, type or auditor. Filter groups to display only the views you need. Avoid scheduling conflicts with functionality that automatically sends notifications and updates of appointments to auditors and displays any conflicts (double-booked, out-of-office, etc.). Create an automatic risk-based schedule of future audits based on audit results or the importance of the process, supplier, system, etc. being audited.
- Simplified Approval Processes:Eliminate the time-consuming tasks of manually distributing paper reports to all the stakeholders and locating appropriate personnel for signatures. Set up a different default approval group for each type of audit. Notifications are automatically sent when a report needs an approval. The electronic record reveals who has signed and which signatures are missing and can be included as a signature manifest on the issued audit report.
- Increased Visibility of Overall QMS:Track and trend observations by finding, rating and category to better understand where issues are occurring. Connect audit process to CAPA, change control, training and other quality processes. Get a real-time view of the audit process through advanced analytics and reporting, including customizable reports and online charting. Easily identify all weak areas to improve internal processes and prepare for future inspections.
- Checklists:Create multiple checklist templates for different audit types to ensure standardization across your organization. Import standards and criteria from industry regulations, and customize your checklist templates by selecting just the applicable sections. Auditors can complete checklists online, offline through Microsoft Word or on a mobile device.
- Controlled Response Collection:Assign observations to internal users or to external responders via a guest connection to enable direct response entry. Create fully customizable Microsoft Word templates to capture offline responses. Create and track actions directly from the observations.
- Automated Audit Report Creation:Create fully customizable audit report templates and assign them to different audit types. Allow peer review collaborations of reports and submit them for approvals. Create default approval groups for different audit types, and generate PDF documents with watermarks and signature manifests.
- Centralized Audit Management for Multiple Audit Types:Facilitate all the audit-related tasks, activities and reports for various audit types with different requirements and complexities. Enable multiple auditors to collaborate from a single audit workspace. Filter audits by type, status or auditors. Generate global trending reports.
- Fully Satisfies 21 CFR Part 11 Requirements:Limit access to authorized users. Require dual-password approval process. Enforce third-party password certification. Ensure that electronic records are reliable and authentic using a secure, time-stamped audit trail that records the identity of anyone who creates, modifies or deletes an electronic record.
- Closed Loop Process:Create actions ranging from a simple notification through an action item form with a review and approval cycle or up to a full issue review/CAPA process or Deviation form. The Audit Management Software closes the loop for an audit by creating a final consolidated report for management, which includes all the data from the issued audit report, responses and any action information.
For More Information on Audit Management Software Systems
For more information about audit management software systems or the solutions from MasterControl, please don't hesitate to contact a MasterControl representative
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
