Change Control Templates

White Paper Provides Information About Change Control Templates or Forms.

Titled Change Control Templates reflects quality improvement in FDA ISO environments, the white paper (see download below) discusses what FDA inspectors and ISO auditors consider the most critical regulatory principles in change control.

Given the multitude of ongoing processes for document change (involving design specs, formulations, SOPs, specifications for raw materials, etc.), the considerations discussed in this white paper are important, and can serve as the change control template for companies who want to ensure compliance and speed up their processes.

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White Paper: Change Control - Continuous Quality Improvement in FDA and ISO Environments
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White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments
White Paper: ISO 9001-2000 Standards: Automating Quality Systems
Product Data Sheet: MasterControl Change Control™

What Should Change Control Templates Look Like?

At a minimum, the change control templates or change forms should provide pages for the change submission, evaluation, approval/ rejection, implementation, verification, possible validation and close of the change.

The change control templates also need to be automated. The change management software from MasterControl provides the benefits outlined below:

  • Form-to-Form Launching
  • Dependent Routing
  • Dynamic Organizers
  • Powerful Reporting Tool

For More Information on Change Control Templates

For more information about the processes associated with a change management or change control templates that can benefit companies, please feel free to contact a MasterControl representative.