Change Control

In a regulated environment, Pharmaceuticals and/or Medical Devices companies are expected to establish procedures for effective change control  in order to ensure product quality and safety. Given the multitude of ongoing processes for document change (design specs, formulations, SOPs, specifications for raw materials, etc.), automated change control systems are critical. Not only can software for change management assure compliance, it can also greatly enhance a company's productivity.

Change Control Challenges


MasterControl Advantages

Poor Change Control Turn-Around
Timelines are essential in change control systems. A manual system that relies on paper-based documents to generate necessary data and old-fashioned legwork to route and track submissions and change orders is likely to have poor turn-around for change implementation.

Excellent Turn-Around with a Change Control System
MasterControl integrates and streamlines the entire change control system procedures for faster turn-around. It offers a best-practice form that incorporates priority level (by identifying the change as routine or temporary or emergency), as well as escalations. Plus, reports provide real-time status for all change control tasks.

Disconnected Change Control System Processes
Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. In the context of change control system, this could mean lack of follow-up, late notifications, and tasks not completed by deadline. Suppliers could be making changes without proper and timely notification.

Connected Change Control Software
MasterControl is an integrated change control software that connects different departments with data and processes under a secure and centralised system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.

Training not Integrated with Change Control Software
In a manual system, it is difficult for employees to keep up with all the changes in SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system for which MasterControl's Change control software was introduced.

Integrated Training System with Change Control System
With MasterControl, the change control software 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, and even includes automatic grading.

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