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MasterControl Validation Strategy and Advantages

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Data Sheet 1 Data Sheet MasterControl Validation Strategy and Advantages As practiced by many regulated companies today, validation is the costliest, most time-consuming aspect of installing or upgrading enterprise quality management software (EQMS). Validation does not need to be a burden that prevents companies from investing in software that can improve product quality, safety and efficiency. MasterControl is committed to ensuring its approach to software validation alleviates the time and cost burdens that antiquated software validation processes often impose. MasterControl's Validation Strategy For companies regulated by U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), validation of their electronic systems is required. While the FDA requires validation, it does not mandate a specific validation methodology. The federal agency wants companies to document how they intend to validate and then prove they did it that way. Regarding validation activities, the FDA recommends that companies pursue the "least burdensome approach." To that end, MasterControl has based its formal validation strategy on a set of four guiding principles. These principles collectively enable companies to minimize the validation effort required to use MasterControl software, while making their processes more efficient and robust. Guiding Principle 1: Validation should be part of change control. Change control provides a framework to manage software changes, such as an installation or upgrade, in a controlled manner. With validation incorporated into a solid change control process, the overall validation effort is more likely to remain focused on verifying that the change meets user requirements and is less likely to experience the scope creep often associated with validation. Guiding Principle 2: Validation should be risk-based.

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