Compliance

Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
Features
Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
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 Documents
Guidance Docs

Data Privacy: A Compliance Blind Spot

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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United States GMP Compliance Documents

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...