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Blog & Updates

April 17, 2015

Mock Audits

Mock audits are an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals. As such, pharmaceutical executives should understand what a mock audit is, why they should arrange for a mock audit to be conducted, and what a standard mock audit entails. What Is A Mock Audit? Mock audits are simulations […]

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What is Unique Device Identification (UDI)? First, it is important to understand what exactly makes up a UDI. As defined in FDA’s final rule, a UDI is an alpha-numeric or numeric code on the device label, packaging or product, in both plain text and machine readable format. It is made up of two-parts, a Device […]

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To remain competitive, companies must be able to market the investigational products that they manufacture. However, no company can market an investigational product in the United States without approval from the Food and Drug Administration (FDA). New Drug Applications (NDAs) are one of the final steps that a company takes before a drug receives approval, […]

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With the progression of technology, it has become evident that there is a place for electronic documentation in clinical research. One area of particular benefit includes the informed consent process. Electronic informed consent (eIC) has the potential to offer great advantages over the traditional paper consent process. If used correctly, eIC can serve as an […]

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While not directly called out as required in the Food and Drug Administration’s (FDA) Quality System Regulation (21 CFR 820), a good Validation Master Plan (VMP) is critical to executing a solid process validation program. A Validation Master Plan provides medical device manufacturers with a roadmap, by outlining the process validation requirements and providing justification […]

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