In FDA and ISO environments, the concept of change control is closely interwoven with compliance. Under the FDA's Quality System Regulation (QSR) for medical device companies ( 21 CFR Part 820 ), a medical device change control software system is required for design changes ( 820.30 ), document changes ( 820.40 ), and production and process changes ( 820.70 ).
The MasterControl medical device change control system is an integrated quality management software solution suite that is configurable, easy to use, and helps medical device companies attain and sustain compliance.
Sélectionnez toutes les ressources que vous souhaitez télécharger.
One of the risks faced during the implementation of a change in a manual medical device change control system is communication breakdown. It is imperative to maintain constant collaboration between employees, departments, and stakeholders as various processes existing within the system are adjusted so that changes are properly planned and implemented. Change control activities include task follow-ups and notifications. A delay in change control processes implies that communication is disconnected because suppliers may be making changes without proper and timely notification.
As a requirement of CGMP 606 as it pertains to medical device change control software, MasterControl provides an integrated solution that helps various departments stay connected with data and processes under a secure web-based platform that ensures connectivity through task assignment, routing, scheduling, notification, and escalation of incomplete tasks. In a continuous effort to improve communication between the different stakeholders, MasterControl's medical device change control software is designed to facilitate communication between suppliers and others residing outside the company's domain, including off-site or travelling employees. This means that the medical device change control software system guarantees active and effective collaboration between various stakeholders situated virtually anywhere.
The primary characteristics of effective change control processes are effectiveness and timeliness. With legacy medical device change control systems, it may be impossible to run an effective change control cycle as there is a constant delay in routing and tracking submissions. The turnaround time for change orders is poor which inevitably results in inefficiency.
MasterControl medical change control systems are based on best-practice forms that are completely automated. These forms reduce redundant data entry and eliminate any chance of errors. One of the best-practice forms built in to the MasterControl medical device change control software system incorporates priority level (by identifying the change as routine or temporary or emergency) as well as escalations. Plus, system reports provide real-time status for all change control tasks.
Apart from the change control processes that are implemented within the system, it is also important to train employees, stakeholders, and various other users about these changes. Most legacy medical change control systems lack the infrastructure to allow room for training as procedures residing in the change control process are often not properly integrated.
With MasterControl's medical device change control software, the change control process can be integrated with the training application. Any change to a document that warrants new training will automatically invoke training tasks. MasterControl can automate the process of distributing online exams with the training tasks, and even includes automatic grading.
Incorporating change within an existing system is always tricky, especially when the change is associated with the risk of noncompliance with FDA, CGMP, or ISO regulations. A truly closed-loop process within the MasterControl medical device change control system enables users to monitor and analyze each phase of change control for better manageability. The software validation requirements that apply to software used in manufacturing and process control are regulated by 21 CFR 820.70 and 21 CFR 820.30. Medical device manufacturers have to convince the FDA through a pre-market notification process that their devices are safe and effective. Moreover, manufacturers must also comply with the Quality System Regulations (QSR) for controlling the methodology and processes used by the manufacturer to design, develop, manufacture, and maintain their devices. All these regulations require a certain level of consistency in the product lifecycle which also in turn helps to eliminate any outstanding or potential risks that may result in nonconformity.
The majority of the medical device change control software on the market lacks an adequate risk assessment component. Such shortcomings may lead failures that are untraceable and may lead to disastrous results. To bridge this gap, MasterControl's medical device change control system provides a robust risk management component that helps users track each step of the change control process. MasterControl's medical device change control software system enables top level management to monitor every stage of the change control process and also derive timely reports to evaluate, study, and extract important results that in turn allow them to make better decisions about the company's future.
Our team of experts is always available to answer your questions about medical device change control software systems. Call a MasterControl representative to get your questions answered by calling us toll free at 800-825-9117 or contact a MasterControl representative online.