Integrated Quality Management Software Systems (QMS)

Having a fully integrated quality management system (QMS) in place enables your organization to meet the challenge to drive operational efficiency and improve overall compliance. While market globalization has vastly increased the profit potential for profit for manufacturers and other businesses, it has also intensified competition and the pressure to produce products faster and at a lower costless expensively. The situation is doubly challenging in highly regulated the FDA and ISO environments where , where life science companies must contend with strict regulations from the ISO, FDA, EMEA, and other global regulatory agencies.


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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.
Product Data Sheets
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.

Toolkits & Demos

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
Toolkits
  • 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workloads is especially difficult for companies doing business in regulatory spaces, most of whom are operating with outdated tools, manual processes, and fragmented approaches to quality management.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 20 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
E-Book
  • 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.


Integrated Quality Management Software Systems (QMS)


MasterControl's integrated quality management software system was designed to streamline and automate your quality management processes and facilitate the timely implementation of corporate quality assurance initiatives enterprise wide. By centralizing and integrating quality processes, including the management and reporting of corrective and preventive actions (CAPA), deviations, and complaint handling, MasterControl's quality management software enables your company to effectively monitor and comply with today's increasingly complex and ever-changing government regulations, ISO standards, and industry best practices.

A quality management system (QMS) is an organization's structure, processes, procedures, and resources used to adhere to specifications, standards, and customer expectations in the most cost effective and efficient manner. Regulated companies need quality management systems to improve their quality processes and avoid the financial and credibility damages of non-compliance.

Many companies have paper-based, non-integrated quality management systems installed in various departments. Unfortunately, this does not allow for consistency enterprise wide. Improving quality is not the task of only one department; it's a company-wide responsibility.

The solution to this problem is an integrated QMS system that combines quality, supplier, training and document control together and acts like a portal, allowing you to funnel all quality assurance events through one place.

Without an integrated quality management system (QMS), it's not uncommon to find disconnected quality event management (QEM) tasks. A CAPA may be triggered by an OOS, an NCR, audit findings, customer complaints, or a trend analysis. With manual systems, these sources are disconnected, making data collection slow, incomplete, or worse, inaccurate. It is far better to integrate the CAPA process throughout the entire organization.


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


Improving Quality in Your Organization with an Integrated QMS


With more than a decade of experience automating quality management processes in ISO manufacturing and rigorous regulated environments like the FDA, MasterControl has developed a fully configurable and integrated quality management software system that combines industry best practices with the flexibility to meet every customer's unique needs. The software is designed to help you improve quality throughout your entire organization.

MasterControl's integrated QMS software system 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).

Integrated QMS Resources


For more information about how implementing an integrated quality management system (QMS) throughout your organization can improve your quality control, visit the MasterControl Resource Center. Complimentary white papers, industry-specific literature, newsletters and other downloads are available to help regulated companies improve their quality systems.

Contact MasterControl About Integrated Quality Management Software


Whether you want to learn more about integrated quality management systems or MasterControl's innovative GxP solutions, the MasterControl team can answer your questions. Call 800-825-9117 or contact MasterControl online.

For More Information on Document Control Software Systems

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

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