21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

This Questions & Answers paper is a follow up to Particle Measuring Systems’ webinar, “Understanding 21 CFR Part 11 and Data Integrity Regulations”.

Topics in this paper include:

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

Get answers to your 21 CFR Part 11 questions such as:

  • Can one person hold different levels of accounts (i.e., user, administrator)?
  • Is daily backup of data required?
  • Is a system that uses groups instead of unique logins considered Part 11 compliant?
  • What is ALCOA+?
  • For the physical security SOP, do we really need to write an SOP to say that the server closet is under lock and key? Can this be added into another relevant and already existing IT SOP?

Learn more… Complete the form to download the full paper.





Explore Other Topics

Search Knowledge Center: