Understanding 21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

This FAQ paper is a follow up to the webinar, “Understanding 21 CFR Part 11 and Data Integrity Regulations”. Many thoughtful questions were asked about the specific guidelines of 21 CFR Part 11 relating to data integrity, and how they impact operations. Questions submitted during and after the webinar are answered below. If you have any additional queries for our experts, submit them directly here.

Topics in this paper include:

  • Requirements and Concepts
  • Standard Operating Procedures (SOPs)
  • Monitoring Systems