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Paper: 21 CFR Part 11

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?

COMPLETE THE FORM TO GET THE PAPER

Looking for a 21CFR Part 11 Solution for your cleanroom data?
Look no further than PharmaIntegrity.

PharmaIntegrity Data Management System for Pharmaceutical Industry Data Integrity (21CFR11)

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

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.

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Particle Measuring Systems EN-CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

Education and Training

  • PMS™ Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

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