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Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check

Executive Summary

Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.

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