In the past, it was not uncommon for a medical device clinical trial to be conducted outside of the "mainstream" clinical research industry. However, as the FDA continues to place increasingly more focus on good clinical practices, device manufacturers are finding an increasing number of regulatory groups and guidelines involved with every medical device clinical trial. The integrated GxP process management solutions offered by MasterControl Inc. help navigate device developers through the complex path toward regulatory compliance.
Every medical device clinical trial is expressly designed to answer particular research questions. While searching for answers during the course of any medical device clinical trial, a tremendous amount of documentation is generated that must be properly controlled and managed. Effective document control and GxP process management are key factors in getting a medical device past trial stages and eventually to market. The proven software solutions available from MasterControl provide a central and secure document repository and insure that all documentation generated over the full span of a medical device clinical trial can be efficiently accessed, revised, and controlled within the confines of regulatory requirements.
Watch Related Videos
For many medical devices, the entire basis of the process of getting the FDA's approval is the collection and evaluation of sound clinical data. Without adequate electronic document control systems and proper practices, medical device developers waste time, manpower, and money in trying to manually manage the vast amount of paperwork generated through the course of a medical device clinical trial. The MasterControl Documents software solution, the core application of MasterControl's quality management suite, automates and effectively manages document control processes to facilitate compliance with FDA regulations and ISO quality standards. The secure and centralized document repository that MasterControl provides makes search and retrieval of documentation fast and easy. MasterControl is Web-based, so important documents are available to authorized users from virtually anywhere. The system provides automatic revision control to ensure that users are only working with the most current version of a document. Electronic tracking of all changes and the system's robust reporting capabilities guarantee that users can access the right documents and data they need anytime they might need it during the course of a medical device clinical trial. For more details about the features and benefits of MasterControl Documents, visit the MasterControl websit.
MasterControl has offered top-of-the-line GxP process management solutions to hundreds of companies worldwide since 1993. Based in Salt Lake City, Utah, MasterControl gives users a secure, Web-based GxP process management suite and facilitates compliance for companies regulated by ISO and FDA standards.
To learn more about MasterControl's proven GxP process management solutions and how MasterControl can help streamline the processes involved with a medical device clinical trial, feel free to contact MasterControl representative or call our team of experts toll-free at 800-825-9117.