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:
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
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
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
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