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    Automation Best Practices for Managing Regulatory Processes: Part 2

    This article shares observations from regulatory experts on how to compliantly and efficiently manage change events, such as label or manufacturing changes, with health authorities globally. Introduction In the second of a three-part series, the author provides responses to an independent study designed to identify the primary challenges and best practices when managing regulatory change events and interactions with health authorities. According to more than 50 survey...
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    Standardization Best Practices for Managing Regulatory Processes: Part 1

    This article reviews the most common standardization challenges, including inconsistent data definition, data capture and processes and suggests system consolidation and automation will only succeed if data is standardized and processes are harmonized. Introduction In a three-part series, authors will share rich insights from research and explore identified challenges from a lack of standardization, manual processes and fragmented systems and offer practical advice an...