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MasterControl Validation Strategy FAQ

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Data Sheet 1 Data Sheet MasterControl Validation Strategy FAQ Why Did We Formalize Our Validation Strategy? At MasterControl, we believe our customers should be able to focus their time and efforts on their business activities rather than on the business of validation. We believe our software can help make our customers' processes more robust and efficient. By minimizing the validation effort required to use MasterControl software, our customers can focus on using the software to help provide life- changing products to more people sooner. What Are The Guiding Principles Of Our Validation Strategy? • Validation should be part of change control. • Validation should be risk-based. • Validation should leverage as much work of trusted vendors as possible. • Customer performance qualification (PQ)-level testing should focus on critical business processes (CBP). Why Is Validation Part Of Change Control? An installation or upgrade is a change to your system, and change control provides a framework to manage these changes. By making validation a part of change control, it is more likely to remain focused on verifying that the change meets the user requirements and less likely to experience the scope creep often associated with validation. Why Risk-Based? The "risk-based" terminology has been in use for over a decade, and it is commonly accepted across industries and regulatory bodies. Taking a risk-based approach ensures that critical processes are the focus of testing and allows employees to focus on their core business tasks.

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