|Disconnected Change Control Processes|
Communication breakdown is likely to happen in a quality management system that consists of disconnected tools and processes. In the context of change control, this could mean lack of visibility and follow-up, late notifications, and delays in task completion. Change information is often dispersed and difficult to compile in a logical manner. In worst case scenarios, recalls cannot be bracketed because there is an inability to compile a proper change history.
|Connected Change Control Processes|
MasterControl is an integrated solution that effectively connects users, data, and processes under a centralized system. This connectivity vastly improves communication and efficiency, and helps ensure that issues don’t fall through the cracks. MasterControl provides visibility into upcoming changes and prevents material disposition information from being incomplete or going missing.
|Poor Change Control Turnaround|
Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data, and legwork to route and track submissions is likely to have poor turnaround for change implementation.
|Excellent Change Control Turnaround Cycles|
MasterControl integrates and streamlines the entire change control process for faster turnaround. An easy-to-use graphical workflow designer that incorporates escalation steps allows users to build simple and complex change processes effortlessly. Plus, reports provide real-time status for all change control tasks.
|Training not Integrated with Change Control |
In a manual system, it is difficult for employees to keep up with all the changes in ECNs, ECOs, SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.
With MasterControl, the change control process is integrated with training management. Any change to a document/process that warrants new training will automatically trigger training tasks based upon training requirements set during the change control process. In cases where training is not warranted, justification must be provided as to why.