A standard operating procedure (SOP) is a company’s documented method for its business processes. As such, it’s important to set up guidelines for those SOPs before they are written to ensure uniformity and that all legal and regulatory requirements are satisfied.
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MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
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