The only constant in life, business, and quality management is change. In FDA and ISO environments in particular, effective change control management is required as a way of improving product quality and safety - and ensuring compliance.
|Kostenlose Ressourcen herunterladen|
MasterControl Advanced Packet Types™ is a software solution designed to automate and effectively manage every step of the change control process, from initiation through actual implementation, verification, and completion of a project. MasterControl has the ability to create multiple change packet types that can be used to greatly streamline complex change control processes. Using MasterControl, new packet types can be configured with both custom and preconfigured fields to automatically capture data pertinent to change control activities. The integrated MasterControl solution also helps prevent the use of incorrect components in manufacturing due to insufficient disposition data on an engineering change order (ECO) that may otherwise result in rework or scrap.
Here’s how companies can use MasterControl to resolve major change control challenges:
Change Control Challenges
MasterControl Advanced Packet Types Change Control Solution
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.