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:
|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?
MasterControl provides professionals with superior tools to conduct and manage the perfect audit. With MasterControl’s unrivaled audit management system, auditors can:
- 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
Features and Benefits of MasterControl's Audit Management Software Systems
Simplifies an Auditor’s Job - MasterControl Audit software has designed to make life simpler for your auditors. The audit management system enables auditors to use tools they are already familiar with to get their work done.
- Easy to Use Offline Audit Tool: The audit management system allows auditors to conduct their audits using a tool they are familiar with: Microsoft Word. A Word plug-in allows auditors to capture their observations, rate their severity, categorize them, etc., all within Word. Checklists can optionally be configured and embedded directly within the tool. When the auditor is back online, he or she may simply connect and upload the audit directly from Word.
- Automatic Audit Report Creation: MasterControl’s audit management software solution can automatically create rich text final audit reports, ensuring that auditors do not have to reformat their findings when preparing their audit reports. This way professional final audit reports can be created with the least amount of effort.
- Audit Workspace: The audit management system provides the audit team a workspace for each audit that allows them to manage all the information about the audit, such as type of audit, dates, summary, scope, conclusion, audit team, observations, etc. It is also the area for gathering such information as audit agendas, cover letters, and checklists.
Delivers Powerful Tools to Compliance Managers - With MasterControl Audit software, regulatory and compliance managers have a powerful set of tools to manage their team and audit processes.
- Simplified Audit Planning and Scheduling: The audit management system automatically generates an audit plan based on desired frequency and risk. The plan can be updated through a drag and drop calendar interface. Scheduling conflicts are automatically detected for easy resolution (i.e., double booked auditors, audits scheduled on a holiday, auditor is out of office, etc.). Audit managers are able to efficiently and effectively control audit schedules, allocate resources, and manage risk. Auditors also receive appointment emails that enable them to book their individual calendars.
- Connected Solution: The MasterControl audit management software solution is tightly integrated with MasterControl’s Risk, Supplier and CAPA applications, providing a comprehensive solution that facilitates efficient management of both internal and supply chain risk. The audit management system also integrates with other existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive custom coding.
- Closed Loop Process: Actions can be launched directly from the audit workspace to ensure issues raised during the audit are tracked to closure. Pertinent information from the audit observation is automatically entered into the appropriate action form (CAPA, SCAR, Issue Review, etc), reducing data entry. It also shows the history of the entire process. Links are maintained so users can review a completed process and trace the actions back through the chain of events.
Provides Peace of Mind to Executives - Regulatory and quality executives can rest easy knowing that the MasterControl audit management software systems is helping to manage their compliance programs. They have real time access to important data always at their fingertips. Additionally, MasterControl’s fully integrated quality suite provides them confidence when their organization is subject to customer or regulatory audits.
- Compliant System: MasterControl allows continuous compliance by ensuring your quality system is always ready for inspections and audits. The audit management system allows users to easily create and modify checklists, optionally score checklists, and manage standards and criteria per standard clause.
- Analytics and Reporting Tool: MasterControl’s powerful reporting capabilities include dashboard, drill-down, and scheduling features. The Analytics tool can be used to trend audit observations by category, checklist criteria, standard, supplier/site, or rating, as well as trend audits by auditor, month, site, and so forth.
- Automated Tasks: All tasks pertaining to the audit management process, including notification, follow-up, and escalation of overdue assignments are automated in the audit management software. Automation helps simplify the compliance environment, making it easier to stay compliant.
Alleviates IT and Project Management Concerns - The MasterControl audit management software system has been designed to be easy to validate, implement, and maintain which makes life a lot easier for those tasked with rolling out an enterprise software system.
- Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
- Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in the audit management process from virtually anywhere.
- Unparalleled Validation: For FDA-regulated companies, MasterControl offers a validation approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl’s continuum of innovative products and services include the revolutionary MasterControl Transfer OQ.
- Product Training: MasterControl’s Professional Services team, consisting of former auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster.
- Technical Support: Choosing MasterControl means getting the necessary technical support to ensure audit management software project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.
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