Good Manufacturing Practice (CGMP) regulations and ISO international quality standards require change control, which refers to the documentation, review and approval of critical changes in quality procedures by the quality control unit. In view of the large amounts of documents that need to be managed for regulatory purposes, more and more life sciences companies are using change control management software to ensure compliance.
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Challenges |
Solutions |
Disconnected Processes A manual system doesn’t have the capability to connect the change control process with other quality processes. The lack of connectivity often leads to communication breakdown and delays in addressing crucial changes in procedures and documentation. |
Connected Processes MasterControl is an integrated platform that connects the change control process with other quality processes for a holistic approach to compliance. The seamless connectivity greatly improves efficiency and ensures that no tasks fall through the cracks. |
Inefficient Process A paper-based system requires manual distribution and follow-up of common tasks. Such a labor-intensive process is inherently inefficient. |
Increased Efficiency MasterControl automates quality management, from routing through approval of documents, forms and tasks. It makes search and retrieval of documents easier and greatly increases overall efficiency. |
Training Is Not Integrated GMP regulations require that when an important change that impacts product quality is made, all affected personnel must be trained on the change. This is harder to do in a manual system that doesn’t connect change control with training management. |
Integrates Training With MasterControl, any important changes that require training of personnel will trigger the distribution of training tasks upon approval of those changes. This helps ensure that affected personnel will be able to implement the changes properly. |
Lack of Visibility Changes in documents and procedures are not readily visible in a manual system. Tracking down change history and related documents can be very inefficient for stakeholders and auditors alike. |
Increased Visibility MasterControl makes the change control process visible to all authorized users. The system provides an audit trail that shows the reasons for changes, who made them, and when. |
MasterControl automates and streamlines every step of the change control process, from submission through approval and implementation. It provides robust change control tools to help users implement changes in procedures, policies and documents efficiently and in a compliant way.
A fully automated system optimizes the change management process.
Industry best-practice forms are an important part of MasterControl’s change control software solution. The forms cut down data entry and minimize user errors. To boost risk management, the forms prompt users to assess a change and identify it as either routine, temporary or emergency, and whether it calls for training, validation or other requirements.
For regulated companies, change pertaining to quality management must be performed according to approved policies and procedures. Approval in this context implies proper review, investigation and testing. A change is typically introduced by an initiator, who doesn’t necessarily have to be the person responsible for implementing it. After a change is initiated, it will go through a process of review, investigation (if necessary) and approval.
In MasterControl’s change control system, documents, forms and tasks move through an approval cycle through a packet. Information about a change that has been reviewed and approved can be gleamed from the packet, including a description of the change, reason for the change, disposition and notes. Advanced packets typically offer more options to the user.