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.
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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.
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:
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.