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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Design control is the core of good quality assurance practices. Particularly important for medical device companies, FDA and CGMP requirements emphasize sound quality system practices that are published under the 21 CFR Part 820 regulations. These design control principles enable manufacturers to develop compliant design and development processes. The established regulatory framework also serves as the basis for quality assurance and engineering principles. The MasterControl DHF and MasterControl Documents solutions are integrated parts of the MasterControl software suite that automates electronic document management and design control processes in an efficient and cost-effective manner.
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.
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.
MasterControl DHF JumpStart provides the perfect design control solution for collecting, organizing, and reviewing all the documents necessary to meet FDA requirements. The software is specifically engineered to automate the design control process at an affordable price for startup and small-sized medical device companies.
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.