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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Relevant 21CFR Part 11 Data Integrity Materials
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
Complete Cleanroom Contamination Control Solutions
Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.