Walter E. Washington Convention Center Washington DC EHR and Part 11: Friends or Foes? Electronic Health Records in a Clinical Trials Context: Back to Basics When is an EHR a regulated electronic record per 21 CFR part 11? What is the impact on EHRs when they are regulated electronic records (e.g., access to EHRs by […]

FDA Training Facility Rockville, MDThe PSG partners will present the following subject as part of the FDA’s annual enforcement training for field inspectors: Auditing Electronic Systems: Independent Consultant Perspective. The session objectives are as follows: Demonstrate what to look for regarding compliance with 21 CFR part 11 Identify software development/acquisition models most frequently utilized in […]

In the context of the advent of risk-based monitoring and the new technologies, new applications of existing technologies, new business processes, etc., that will be brought to bear as a result, the PSG partners developed and presented a session titled “Auditing” the Auditor: an Auditee’s Bill of Rights. The session focused on the behavioral patterns […]