Managing Changes


Successful Change Management Requires Speed and Efficiency

Managing changes within a regulated or ISO enterprise can be challenging. This is especially true given the enormous number of ongoing processes for document change to design specs, formulations, SOPs, raw material specs, etc.

A pre-configured, multi-page best practice change request form can help tremendously by prompting users to enter information about the change, then tracking the change through its evaluation, approval/ rejection, implementation, verification/validation and closure.

Please feel free to download the following literature about software for change control and managing changes:

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




Process for Managing Changes gets Launched Directly from a CAPA

With change management software from MasterControl, with the proper authorization, a change form can be launched directly from a CAPA. MasterControl maintains the links so that authorized users can review the completed process for change management to see what triggered the change.

Relevant information from the CAPA form is automatically transferred to the change form.

Managing Changes through Training Management

With MasterControl, the change management process can be integrated with Training Control. This allows a change to a document/process that calls for new training to create new training tasks automatically. The new training tasks will be sent to the relevant employees' emails.

This capability ensures continuous regulatory compliance and keeps your quality system in a continuous state of inspection or audit preparedness.

For More Information

To learn more about managing changes and how MasterControl can help, please contact a MasterControl representative