21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

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?



Relevant 21CFR Part 11 Data Integrity Materials

Data Trending Requirements Annex 1, Rev 12

The New Normal & Data Integrity eSignatures

Remote Audits in a New Normal World

Particle Counter Data and Cleanroom Solutions in the New Normal: Part 1

Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)

Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)

21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

Tackling the 21CFR11 Challenge: From Paper to Paperless

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