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Case Study: FDA Regulated Industries Coderant conducted a comprehensive CMC and supply-chain audit to bring a maker of compressed medical gas in compliance with FDA regulations. This audit included validation of multiple sites and the production of standard operating procedures (SOPs) which were integrated in a successful response to a 483 notice from the FDA. |
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At Coderant, we can develop and implement systems that improve manufacturing efficiency. We have extensive experience with inventory management systems. Among the many practical uses of our IDeAS™ application has been to assist tracking in warehouse, distribution centers, and shipping facilities. We also can build systems which will expedite approvals, authorizations, and other notifications tied to purchasing functions. |
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