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Conveying Systems
Research Library
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Aptuit
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Pharmaceutical and biotech companies of all sizes are increasingly turning to third parties to execute some or all of their clinical supply activities. There is a need for these companies to control and track these activities in their information systems.
This article addresses the various methods in which the activities of third-party supply contractors and IVRS (Interactive Voice Response ...
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TUV SUD America Inc.
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The voluntary certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products in the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device Directive and In Vitro Diagnostic Directive) ...
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BatchMaster Software
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The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced ...
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Blue Mountain Quality Resources, Inc.
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People who live and breathe maintenance every day are instinctively aware of the benefits of maintenance improvement: lowering costs and increasing output while still remaining compliant. The intent of this paper is to provide a framework for building the formal justification for investing in a CMMS (Computerized Maintenance Management System) or EAM (Enterprise Asset Management) system as part ...
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Xcelience, LLC
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The formulation of drugs into capsules is often utilized in early phase development due to the relatively quicker formulation-development process. The bioavailability of the poorly soluble drugs can be significantly increased when formulated in a solubilized form in a capsule (i.e. liquid or semi-solid filled capsules). Acidic degradation and dyspeptic side effects associated with some compounds ...
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