The software from MasterControl to automate the change management process provides a change form for collecting and tracking data related to change orders.
The multi-page, best practice change management process form is pre-configured, and prompts users to enter information about the change, then tracks it through the processes of evaluation, approval/ rejection, implementation, verification/ possible validation, and closure.
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Change management is a fundamental constituent in the change control process, which is why it is necessary to start off with careful planning before implementing changes. Companies wishing to incorporate changes to business processes often rely on consultation and the involvement of stakeholders. MasterControl's change management process software provides companies with a platform for collaboration between all parties involved and connects them with the associated processes.
It is vital to have the ability to measure realistically achievable changes. Only by properly analyzing the most important aspects of a change can management completely understand the overall dynamics of a change and the change's effects. Effective change management processes align a company's business strategies for proper assessment and evaluation of the change.
In order to prepare for change, management often relies on several different sources for assistance with data collection, storage, and tracking. With the help of MasterControl software, all important data can be collected using highly customizable forms. The next step, then, is to measure the impact of a change and align it in accordance with the company's overall vision and goals. The MasterControl change control process allows all relevant data to be automatically transferred from the change control form to a CAPA form, which connects quality processes for maximum effectiveness. This automation prepares management to adapt to changes more readily. Administrators also have the ability to review a completed process to see what initiated a change and track its path and consequences.
In order to incorporate a change to a business process, a company must develop a thorough plan to outline and assess the various aspects of implementing the change. MasterControl change management process software provides a web-based solution for companies to document each stage of the change so that changes proposed to existing sets of procedures can be emulated throughout the enterprise. Once a change is implemented, it is important to educate users about the change at a broader enterprise level. To facilitate this implementation, MasterControl change control process software integrates seamlessly with training programs and automatically triggers training tasks once a change has occurred to a document or a process.
Not only does this feature enhance training management and help companies maintain regulatory compliance, it also keeps quality systems in a continuous state of preparedness for inspections and audits.
Other important aspects of the change management process are the gaps and potential risks that may be caused by the implementation of changes. MasterControl change management process software helps companies overcome risks by allowing them to monitor and track changes that may have a larger impact on the business. Measurement of risks and their subsequent level of impact are critical to the development contingency plans for managing, mitigating, and monitoring risks. As such, risk management and analysis is at the root of MasterControl's approach to change management as it is also critical to attaining and sustaining compliance with ISO and FDA regulations.
MasterControl Inc. is an established provider of GxP process management software solutions for FDA and EU- regulated companies. Our software solutions, and the dedicated support of our technical and customer service groups, have helped over 500 companies around the globe attain and sustain effective change management process according to regulatory compliance.
For more information about the change management process, and how MasterControl can help with change management software, please contact a MasterControl representative.