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Quality Management Software Systems

The MasterControl Enterprise Quality Management System (EQMS) enables companies to eliminate paper-based quality processes while adhering to strict FDA regulations and ISO quality standards. Replacing paper-based quality management systems with automated quality management software systems dramatically improves a company's ability to comply with regulations and quality standards, while increasing operational efficiency, improving product quality, and accelerating time to market—all at the lowest possible cost.

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Product Information

Discover how MasterControl Quality Management System can manage your Document Control process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • With more than two decades of experience in rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility required to meet customers' unique needs. Learn how MasterControl software solutions not only help companies attain compliance, but sustain it year after year by optimizing quality and business processes and fostering efficiency.
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Consulting Services
  • MasterControl Quality and Compliance Consulting™ (QCC) offers intensive one- and two-day quality process workshops designed to help you stay one step ahead of even the most complex developments. The training is relevant regardless of the electronic quality management system (QMS) solution you use, or even if you do not have an automated system in place.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your QMS program.

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Interactive and Live Demonstrations
  • MasterControl offers the most complete choice of integrated solutions covering all core areas necessary to successfully maintain quality and compliance processes, as well as a variety of services based on industry best practices.
Product Data Sheets
  • Maintaining compliance and keeping pace with burgeoning workloads is especially difficult for companies doing business in regulatory spaces, most of whom are operating with outdated tools, manual processes, and fragmented approaches to quality management. This toolkit collects 25 MasterControl white papers, videos, and more expertly-developed resources designed to improve and streamline your company's quality management processes.

Educational Materials

Get insider information about the most relevant issues in Quality Management Systems today, and how to navigate and overcome the complexities of FDA regulatory compliance.

Product Data Sheets
White Papers
  • A lack of quality can cost an organization millions of dollars in rework, scrap, recall or even liability lawsuits. This white paper shows how an optimized quality management system (QMS) can help a company avoid quality roadblocks and form the foundation for long-term regulatory compliance and, ultimately, for ensuring market success.
  • Learn how to articulate the business case for investing in an enterprise quality management system (EQMS). Explore five key ways to get buy-in from senior leadership when it comes time to establish or expand the EQMS.
Educational Materials
  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

Educational Materials

Analyst Reports
  • Market-leading manufacturers are leaving outdated or disconnected quality management solutions behind. Find out why developing closed-loop quality processes, supported by quality management system (QMS) technology, is having a sizable impact on manufacturers' quality performance.

Quality Management Software Systems Are Key

An electronic quality management software system (EQMS) that is automated and connects all departments is essential for a regulated or ISO-compliant company. A QMS or a TQM (total quality management) system can connect each phase in a product's development lifecycle with every department in a company. This gives everyone an opportunity to provide feedback. Automated routing, with escalation, ensures the rapid responses to inputs needed from other departments. By building quality into products as opposed to forcing QA to bear the burden of the responsibility, everyone (engineering, regulatory, QA, manufacturing, sales and marketing) wins.

Closed loop quality management system process flow using MasterControl's Enterprise Quality Management Software System (EQMS)

How Can MasterControl's QMS Benefit You?

With more than a decade of experience automating quality management processes in ISO manufacturing and rigorous regulated environments like the FDA, MasterControl has developed an integrated QMS that combines industry best practices with the flexibility to meet every customer's unique needs.

MasterControl's EQMS consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and forms-based quality and business processes under a single Web-based platform. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), and ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949).

The MasterControl EQMS includes the following integrated applications:

Document Control

MasterControl Documents™ helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.

Corrective and Preventive Action System

The MasterControl CAPA™ system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.

Change Control

MasterControl Change Control ™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks but of the entire quality system.

Training Management

MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

Nonconformance Automation Software

MasterControl Nonconformance™ is a robust EQMS designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants. Training will automatically invoke training tasks upon approval of the change.

Quality Audit Management

MasterControl Audit™ automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.

Customer Complaints Software

MasterControl Customer Complaints™ streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.

Forms-Based Processes Automation

The MasterControl Process™ electronic quality management system automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

Electronic Submissions

MasterControl Submissions Ready™ allows organizations to accelerate the preparation and organization of submissions documents for utilizing FDA- and ICH-compliant submissions templates in combination with MasterControl's unrivaled document management solution. MasterControl's integrated solution ensures that authors are using the most up-to-date version of a template and that submission documents are securely stored and organized in a logical file structure.

Supplier Management

MasterControl Supplier™ manages all supplier status and quality information (such as conforming material reports) is contained in a single, easily accessible location. In addition to providing an effortlessly maintainable approved vendor list (AVL), the Web-based Supplier platform features a user-friendly interface for accessing all documentation and records related to each supplier. The AVL is made available organization-wide and is updated in real time. MasterControl Supplier is designed to meet the needs of experts who need to maintain all supplier status and quality information (i.e., approval status, contact information, recent audits, non-conforming material reports, CAPA reports, contracts, approved goods/services, supplier ratings, links to analytics reports, etc.) in a centralized location that is easily accessible.

For More Information on Quality Management Software Systems

For additional details about the Quality Management Software Systems from MasterControl, please feel free to contact a MasterControl representative.