Companies in FDA and ISO environments must manage different processes in multiple areas (R&D, manufacturing, regulatory, etc.) plus the complex relationships among these processes. Business rules help managers and employees streamline operational functions, solve issues in a more proactive way to ensure compliance, and maximize productivity.
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Through MasterControl Rules, a manager can set thresholds for quality events such as CAPA, customer complaints, and raw material nonconformances, which will trigger notification. For example, MasterControl can send automatic notification to the manager when a certain product receives 10 customer complaints. This will alert the manager to take appropriate action (i.e., launch a CAPA investigation) as soon as possible, instead of waiting for the weekly or monthly customer complaints report.
For most automated systems, control rests on the system administrator, coordinators, and managers. They are responsible for monitoring the system and they must be vigilant in tracking tasks and deadlines. This setup does not foster individual user accountability.
MasterControl empowers individual users by giving them the capability to manage their own tasks. From the system administrator to basic users, individuals will be accountable for monitoring and completing their tasks with the help of rules.
Tracking tasks manually can be cumbersome and time-consuming. Some tasks are likely to fall through the cracks without a proper tool for monitoring and escalation.
MasterControl automates tracking of tasks and monitoring of progress for a more efficient process. Users can create dependencies for a more effective workflow.
Automation is likely to produce more data at a faster rate. If employees are unable to keep up with increased data, turnaround is likely to be slow.
This solution provides business rule capability in all user levels to help them stay on top of things. Creating rules that prompt the next step in a process also speeds up turnaround.