Compliance

Features
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to assess suppliers of GxP-regulated IT services.
Guidance Docs
1 Introduction What should be planned for when implementing a new computerized system, such as a clinical trial database? For clinical computerized...
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FDA's Regulatory Procedures Manual Provides information on internal procedures to be used in processing domestic and import regulatory and enforcement activities. While the RPM is intended mainly to provide guidance to...