The MasterControl Quality Management System (QMS) enables companies to eliminate paper-based quality processes while adhering to ISO quality standards and strict regulations imposed by FDA and other global regulatory bodies. Replacing manual paper-based or hybrid (part electronic and part paper) 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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A QMS that is automated and connects all departments is essential for highly regulated companies, or those that must conform to ISO quality standards. A QMS or a total quality management (TQM) system connects every department in each phase of the product lifecycle from concept to commercialization and beyond. This gives each department a collaborative environment in which to provide feedback throughout the product lifecycle. Automating these core quality processes ensures rapid responses to inputs needed from other departments. Designing quality into products as opposed to forcing quality assurance (QA) to bear the burden of the responsibility; helps everyone (engineering, regulatory, QA, manufacturing, sales and marketing) win.
Whether upgrading a paper-based or hybrid quality system to improve accuracy, efficiency, and audit-readiness, or consolidating multiple legacy and vendor systems to a single unified quality platform, MasterControl has a quality suite designed to meet these unique needs.
MasterControl has been delivering quality excellence solutions for more than 25 years to meet the needs of highly regulated industries and to embrace new levels of digitization and automation that require more dynamic, connected and scalable quality practices.
Built on the MasterControl Platform™, the MasterControl Quality Excellence™ solution 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), deviations, and other documents- and forms-based quality and business processes under a single web-based platform. More than 1,000 companies worldwide rely on MasterControl to facilitate compliance with FDA and other global regulations, such as 21 CFR Parts 11, 210-211, 820, 606; GLP; GCP; GMP; and ISO quality standards, such as ISO 9000, ISO 13485, ISO 14000, ISO/TS16949.
The MasterControl Quality Excellence solution is comprised of three flexible quality suites that are scalable to fit the needs of companies of every size. Each MasterControl Quality Suite combines configurable products, process applications, validation services and platform functionality to provide unmatched performance and value.
MasterControl Quality Suites consist of combinations of the following integrated quality processes:
Automated Document and Change Control Management
Training and Exams Competency Management
Incidents and Corrective Action Management
Audit and Preventative Action Management
Risk and Mitigation Management
Efficient Design and Specifications Management
MasterControl is committed to driving digital process excellence at every stage of the product lifecycle – from concept to commercialization. Quality is the ultimate business differentiator, which is why we continue to work with customers to replace manual, paper-based processes with solutions that help them bring life-changing products and treatments to market faster while ensuring quality and compliance.
Please feel free to contact a MasterControl representative about questions you may have about quality management software systems.