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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MasterControl Rules™, a part of the MasterControl integrated quality management suite, is a configurable and easy-to-use solution for effective monitoring and management of critical quality events and tasks. It also empowers individual users to manage their own tasks more efficiently and effectively.
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. Our ?continuous validation? approach dramatically cuts the time, pain, and cost involved in validation, making it easier to re-validate future upgrades.
MasterControl's continuum of products and services address different levels of validation needs based on individual risk assessment. They include innovative products and services such as MasterControl Transfer OQ and MasterControl Automated OQ.
Here's how MasterControl addresses some of the key challenges that companies face in monitoring and managing quality events:
Event & Task Management Challenges in a Quality System
MasterControl Rules™ Software
Ineffective, Reactive Monitoring
It's critical for companies to discover serious problems with products and/or services in a timely manner. For FDA-regulated and ISO-certified companies, this is a matter of compliance. But many companies don't have the ability to monitor issues on a real-time basis. They rely on periodic reports, or simply trust certain people to take the initiative to report serious issues.
Effective, Reactive Monitoring
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.
Lack of Accountability
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.
Poor Project Tracking
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.
Eases Information Overload
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.
MasterControl Rules provides management with the ability to monitor quality events and tasks on a real-time basis, which is crucial in problem solving. Managers who are not involved in a quality process on a daily basis, but are still responsible for overall compliance, will be able to monitor the process through rules. It also gives users the flexibility they need to make the system respond better to their individual requirements based on their roles and rights.
A MasterControl rule has three major components: source data (tasks, InfoCards, form data), criteria (the rule itself, i.e., notify if three days past due), and action (send e-mail). Below is a summary of the solution's features.
Configurable Rules: Rules can be configured based on a company's needs, but the most common type is notification rule, which triggers an alert to affected users, who will then need to take an appropriate action. The notification rule provides a high degree of customization, including frequency, subject line, e-mail text, recipients, etc. The system has the ability to consolidate notifications per user and rule. For example, instead of sending three e-mail notices for three training-related tasks, one e-mail message will be sent alerting the user about the three tasks.
Criteria Functionality: Depending on source data selected by a user, triggers may be based on when criteria are met (i.e., every time there's a task past its due date), or based on a number of records (i.e., every time the system finds an accumulation of 15 CAPAs for a specific product).
Rights-Based Capability: The extent of an employee's rules capability is based on his/her system rights. The two types of rights are rules administration and ?My Rules.? The latter is available on basic and advanced levels.