Contrôle de la conception

Automatisez la procédure de design control pour améliorer l'efficacité et assurer la conformité à la norme 21 CFR Part 820 QSR de la FDA

Les ingénieurs doivent concevoir, développer et tester de nouveaux dispositifs médicaux et, en même temps, s'assurer que toute la documentation nécessaire est en place pour démontrer la conformité aux contrôles de conception. Découvrez comment réduire les difficultés liées à la documentation pendant le processus de design control.

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How can MasterControl DHF for Design Control Benefit You?

Le contrôle de la conception est l'élément fondamental des bonnes pratiques en matière d'assurance qualité. Particulièrement importantes pour les fabricants de dispositifs médicaux, les réglementations de la FDA et les bonnes pratiques actuelles de fabrication mettent l'accent sur les exigences rigoureuses en matière de système qualité établies dans la partie 820 du titre 21 du CFR. Ces principes de contrôle de la conception permettent aux fabricants d'appliquer des processus conformes de conception et de développement. Le cadre réglementaire établi sert également de base aux principes de conception et d'assurance qualité. Les solutions MasterControl DHF et MasterControl Documents sont intégrées à la suite de logiciels MasterControl qui automatise les processus électroniques de gestion des documents et de contrôle de la conception de manière efficace et économique.

MasterControl solutions are founded on the principle that design control practices and procedures should be implemented in the design and development process of the manufacturing methods. The reason behind incorporating design control in the manufacturing system is to facilitate the correct implementation of design and to ensure that the developed product yields the required results. This means that the inputs and outputs comply with the stated set of outcomes. MasterControl Documents provides the necessary platform for streamlining design control documentation. Since MasterControl is an entirely Web-based central repository, all different types of documents can be easily searched, managed, and collaborated upon, regardless of the software used for creating them.

MasterControl automates the routing, escalation, and approval of design control documents. Reviewers can electronically sign-off documents that are then readily available to employees for reference during manufacturing processes. To enable parent-child relationship between tasks, a completion of a task can be made dependent on another task. This provides managers more control and reduces document development life cycle as users are automatically directed to the next task in line.

MasterControl Design Control Tools Offer Unmatched Audit Trail and Reporting Capabilities

A medical device company's primary objective is to incorporate flawless design controls to ensure that designs seamlessly transfer to production which eventually translate into a device that is appropriate for its intended use and complies with the documented standard. MasterControl's time-stamped, secure functionality meets and exceeds 21 CFR Part 11 requirements. MasterControl software documents the identity of the user who creates or modifies an electronic record, when the action occurred, and what changes were made. This helps companies track modifications and control or limit the changes made to existing design and manufacturing procedures.

With the help of advanced analytics and reporting capabilities, manufacturers can also generate standard and customized reports that further enhance management oversight and streamline operations. Ultimately, companies are able to maximize their investment in MasterControl and make sound decisions on the basis of real-time statistics.

How Can MasterControl DHF Help Reduce Documentation in Design Control?

MasterControl DHF JumpStart s'avère la solution de contrôle de la conception idéale pour collecter, organiser et consulter tous les documents nécessaires au respect des exigences de la FDA. Ce logiciel abordable est spécialement conçu pour automatiser le processus de contrôle de la conception et destiné aux jeunes et petites entreprises qui produisent des dispositifs médicaux.

Find Out More About Design Control by MasterControl

Find more information on MasterControl's design control software, by giving a visit to MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.