Automating design control procedures is critical for product quality and compliance. Add to that the regulatory environment in which medical device developers must comply with FDA's Quality System Regulation (QSR), and the task can seem insurmountable. Through the implementation of design control procedures, companies can become more efficient and improve product quality and compliance with global regulatory agencies.
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In a constantly evolving market, medical device manufacturers are under pressure to develop sound devices that adhere to regulatory policies. For a product to be ultimately launched in the market, medical devices must pass through several testing phases that take years to complete..It is imperative for these devices to be able to consistently produce the intended result without any deviance. This brings device control procedures in the limelight that present manufacturers the facility of drafting accurate design controls for illustrating various functionalities of the medical devices.
Adequate maintenance of design history files and related procedures is for a central component of effective design control. With the help of MasterControl design control procedure software, DHF documentation can be easily compiled and managed in a centralized system. By accommodating customer inputs in various formats and document types, MasterControl users can build an online repository of data pertaining to all aspects of a product's design. Our design control procedure software solution is compliant with 21 CFR Part 11 regulations in that allows only authenticated and authorized users to be part of the design control process. The Web-based platform offers easy-to-use search, advanced tracking, and revision control features.
MasterControl's highly customizable design control procedure system is a complete solution that enables manufacturers to maintain accurate audit trails according to regulatory guidelines. The system documents the identity of any authorized user who creates or modifies an electronic record, when the action occurred, and the changes that were made. It is also important to verify and validate the results obtained in testing the medical devices. The software allows manufacturing companies to generate timely customizable or standard reports in order to evaluate the status of the medical devices in development. This in turn also enables the companies to make sound business decisions. To keep the design control procedures aligned, tasks can be made dependent on other tasks, which gives managers better oversight and control.
MasterControl's compliant design control procedures software system easily integrates with other applications, which enables various inter-departmental operations for ERP, LIMs, and accounting and human resources departments. In addition, because the system is automated, documents can be routed to various departments along pre-defined workflows.
The MasterControl design control procedures software system automates and simplifies forms-based processes. Pre-built and customizable forms enable easy and error-free data entry. Once in the system, data can be automatically transferred to various systems, processes, and other forms for enacting other tasks and procedures. In short, MasterControl software has proven to be the ultimate solution for manufacturing companies looking to refine and enhance their design control practices.
To learn more about design control procedures and change management software solutions, please contact a MasterControl representative.