FDA Case for Quality has three priorities for addressing the barriers to quality that were identified. One of these priorities is Focus on Quality. FDA and Case for Quality stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. In this blog and subsequent webinar, we will discuss document control practices that will lead you to higher-quality outcomes.
Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or multiple regulators. In this webinar, Seabrook discuss in the context of FDA, 21 CFR 820.40., document controls.
FDA:CFR 21 820.40 Document control states, “Each manufacturer shall establish and maintain procedures to control all documents that are required by this part”. But the documents come from multiple sources defined by other subparts, these subparts include:
820.30 – Design Controls
820.180 – General records requirements
820.181 – Device Master Record
820.184 – Device History Record
820.186 – Quality System Record
Therefore all of the critical documents that are generated or acquired need to be managed effectively. Document control is not a stand alone requirement but is part of the closed loops that run through the complete design and manufacturing process.
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