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.
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.
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).
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.
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.
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