Change Control Software for Medical Devices

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.

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.