21 CFR Part 11 & Data Integrity: Frequently Asked Questions

This FAQ paper is a follow up to Particle Measuring Systems’ 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.

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?


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