Change Management Process

MasterControl ensures that nothing is overlooked during the change management process

The software from MasterControl to automatate 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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White Paper: Change Control - Quality Improvements in FDA and ISO Environments
White Paper: Automating Electronic Engineering Change
White Paper: Managing Change Control to Comply with FDA and EU Regulations
White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments
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Product Data Sheet: MasterControl Documents™
Product Data Sheet: MasterControl Change Control™
Tech Paper: MasterControl Change Control™



Given the enormity of ongoing change management processes for document change to e.g., formulations, design specs, SOPs, and specifications for raw materials, equipment, etc. software for change management is essential.

Change Management Processes are Launched Directly from CAPA form

With MasterControl software, change management processes can be launched directly from a corrective action /preventive action (CAPA)form, connecting one process to the next. MasterControl preserves the links so that users can review a completed process and see what initiated the change.

The change management process automatically loads relevant information from the CAPA form into the change form. Examples of other related MasterControl processes that can launch a change include nonconformance, deviations, customer complaints, and audit software.

Change Management Process Integrated with Training Control

With MasterControl, the change management process can be integrated with Training Control, thereby enabling a change to a document/process that warrants new training to automatically invoke training tasks. Not only does this feature ensure continuous regulatory compliance, it keeps your quality system in a continuous state of preparedness for inspections and audits.

More about MasterControl and Change Management Processes

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 on Change Management Processes

For more information about the change management process, and how MasterControl can help with change management software, please contact a MasterControl representative.


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