Quality
Change Control Management Software
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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Why You Need Automated Change Control Tools
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.
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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. |
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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. |
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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. |
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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 Change Control System Benefits
A fully automated system optimizes the change management process.
- MasterControl streamlines the change control process by automating every step of the process, from change submission through implementation.
- Users and auditors will be able to find all documentation pertaining to change management in a single, centralized repository.
- Best-practice forms prompt users to classify a change (low, medium, high) and categorize it as either routine, temporary or emergency. The forms greatly increase efficiency.
- MasterControl provides a collaboration workspace to make it easier for different teams to implement and manage changes regardless of geographic location.
- Users can launch a change submission form directly from a corrective action and preventive action (CAPA) or another form because the different quality processes are connected.
- MasterControl’s best-practice workflow guides users through the change control process to facilitate compliance.
- MasterControl helps users evaluate a change in terms of training, validation and other regulatory requirements to strengthen risk management.
- MasterControl’s powerful analytics tool lets stakeholders interact with their change control data in meaningful ways, including tracking and understanding past and present metrics.
MasterControl Best-Practice Forms
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.
Change Control Process: What You Need to Know
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.
MasterControl Change Control Software: Use of Packets
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.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
