Quality Management Software Systems

MasterControl's eQMS enables companies to eliminate paper-based quality processes. And in industries that are required to adhere to regulatory standards such as those imposed by agencies such as the FDA or ISO, quality management reaches an entirely new level of complexity. Replacing paper-based Quality Management Systems with Automated Quality Management Software Systems dramatically improves a company's ability to comply with FDA regulations and ISO quality standards, while drastically increasing manufacturing efficiency, product quality, and speed to market, at the lowest possible cost.

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Product Information

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

Product Data Sheets
Product Data Sheets
  • 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

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your Quality Management Software program

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
  • Many companies continue to rely on outdated quality management processes. Is yours? Compare your company's quality management system (QMS) to those in this infographic to see how evolved it really is.
  • Market-leading manufacturers are leaving outdated or disconnected quality management solutions behind.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.
Product Data Sheets
Toolkits
  • MasterControl's QMS Toolkit for quality managers provides a core collection of resources designed to help optimize their quality management system (QMS). Includes: 6 white papers, 5 videos, 3 webinar recordings and more.

Educational Materials

Get insider information about the most relevant issues in Quality Management Software today, and how to navigate and overcome the complexities of FDA and ISO Compliance.

Product Data Sheets
White Papers
  • Especially in strict FDA and ISO environments, a robust quality management system (QMS) is critical to quality and compliance success. Learn six ways to help ensure your organization has an optimal QMS.
  • Quality management system (QMS) solutions can spare companies the unnecessary, and often staggering, costs of poor quality processes. Discover how market leaders are leveraging QMS software to make quality management improvements more strategic and sustainable.
White Papers
White Papers
  • 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.
  • Failure to meet FDA regulatory requirements can have devastating consequences. Find out what safeguards upper management should consider and what steps must be taken to ensure consistent, top-down regulatory compliance.


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.


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 consists of 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 Gateway™ facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.

For More Information on Quality Management Software Systems


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