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Logiciels de gestion de la qualité

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.

Vidéos : en savoir plus sur les logiciels de gestion de la qualité

Ressources gratuites sur les systèmes de gestion de la qualité

Informations sur le produit

Avec le système de gestion de la qualité de MasterControl, vous pouvez non seulement gérer votre processus de contrôle des documents, mais aussi réduire les risques et les délais de commercialisation, tout en dégageant un retour sur investissement.

Données techniques produits
Données techniques produits
  • Fort de plus de deux décennies d'expérience dans les environnements FDA et ISO, MasterControl a développé une solution logicielle intégrée qui combine meilleures pratiques industrielles et flexibilité, afin de répondre aux besoins uniques de chaque client. Les solutions logicielles de MasterControl™ sont conçues pour aider les entreprises à se mettre en conformité, mais également pour les assister année après année en optimisant les processus opérationnels critiques et en favorisant l'efficacité.
Données techniques produits
Services de consultation
  • 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

Des ressources complètes et détaillées pour vous guider dans le développement de votre programme de gestion de la qualité.

Données techniques produits
Démonstrations interactives et en direct
  • 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.
Données techniques produits
Kits d'outils
  • 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

Lisez des avis d'experts sur les principaux problèmes liés aux systèmes de gestion de la qualité et sur les moyens de surmonter et d'intégrer toute la complexité de la conformité règlementaire de la FDA.

Données techniques produits
Livres blancs
  • 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.
  • Découvrez comment présenter un dossier d'investissement dans un système de gestion de la qualité en entreprise (EQMS). Voici cinq arguments clés pour convaincre votre direction de mettre en place ou d'étendre votre EQMS.
Educational Materials
Livre électronique
  • 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
  • Des fabricants de premier plan abandonnent leurs solutions de gestion de la qualité obsolètes ou déconnectées. Le développement de processus qualité en boucle fermée soutenus par un logiciel de gestion de la qualité peut avoir un impact significatif sur les performances des fabricants en termes de qualité.


Les logiciels de gestion de la qualité sont essentiels


Il est essentiel pour les entreprises réglementées ou certifiées ISO de disposer d'un logiciel de gestion de la qualité automatisé qui connecte tous les départements. Un système de gestion de la qualité ou un système TQM (total quality management) associe chaque phase du cycle de développement d'un produit à tous les départements d'une entreprise. Chaque employé a donc la possibilité de partager ses commentaires. Grâce au routage automatisé, associé à des fonctions d'escalade, il est possible de répondre rapidement aux demandes émanant d'autres départements. En faisant de la qualité une caractéristique intrinsèque des produits, plutôt que de laisser le soin aux équipes d'évaluation de la qualité de résoudre les problèmes, chacun y gagne, qu'il s'agisse des départements de conception, de réglementation, d'évaluation de la qualité, de fabrication ou des services ventes et marketing.


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


En quoi les solutions MasterControl de gestion de la qualité (QMS) peuvent-elles vous être utiles ?


Fort de plus d'une décennie d'expérience dans l'automatisation des processus de gestion de la qualité au sein des rigoureux environnements réglementés FDA et ISO, MasterControl a développé une solution logicielle de gestion intégrée de la qualité qui combine bonnes pratiques industrielles et flexibilité, afin de répondre aux besoins uniques de chaque client.

Le logiciel QMS de MasterControl est composé d'applications configurables, connectées et faciles à utiliser permettant d'automatiser, de rationaliser et de gérer efficacement, sur une plate-forme Web unique, le contrôle des documents, le contrôle des modifications, le contrôle des formations, les audits, les actions correctives/préventives (CAPA), les réclamations clients, ainsi que tous les autres processus opérationnels et qualité basés sur des documents et des formulaires. Des centaines d'entreprises dans le monde entier font confiance à MasterControl pour simplifier leur mise en conformité avec les réglementations de la FDA (par exemple, les parties 11, 210-211, 820 et 606 du titre 21 du CFR) et les normes de qualité ISO (par exemple, ISO 9000, ISO 13485, ISO 14000 et ISO/TS16949).


The MasterControl EQMS includes the following integrated applications:


Contrôle des documents


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.


Système d'actions correctives et préventives


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.


Contrôle des changements


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.


Gestion des formations


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.


Logiciel d'automatisation de la gestion des non-conformités


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.


Gestion des audits qualité


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.


Logiciel de gestion des réclamations clients


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.


Automatisation des processus basés sur des formulaires


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.


Soumissions électroniques


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.

En savoir plus sur les logiciels de gestion de la qualité


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