Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
11 Seminary Avenue
Hopewell, NJ 08525
P: 609.683.0756

Computer System Compliance: Dealing with Computer Systems, Part 11, and EHR – What You Need To Know

  • 11
  • Jun
  • Posted by 
  • Events
  • Comments Off on Computer System Compliance: Dealing with Computer Systems, Part 11, and EHR – What You Need To Know

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 monitors and auditors)?
  • What is a “certified copy” of an EHR?
  • What is the role of hard copy documentation (e.g., source worksheets and paper documents) in the world of EHR?

Comments are closed.