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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Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.