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![]() ✔ Site Master Files ✔ What does the document contain? So what is the intent of both documents and are they both mandatory requirements for all manufacturers? The confusion is understandable given that both documents appear to contain similar information. ► I am often asked by new based manufacturers seeking a manufacturing license and implementing a Quality Management System (QMS) what the difference is between a Site Master File (SMF) and a Quality Manual.
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