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21 CFR Part 11 & Data Integrity

Knowledge / Papers

  • Data Integrity: Understand and Comply with GMP and FDA Requirements for 21 CFR Part 11

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  • 21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

    This FAQ paper is a follow up to the 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. Read questions and answers submitted during and after the webinar and also submit questions of your own.

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Relevant Products

  • Facility Monitoring System (FMS): FacilityPro®

    Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.

  • PharmaIntegrity Data Integrity

    Creates a complete contamination monitoring solution for pharmaceutical manufacturers.

  • Cleanroom Particle Counter: Lasair® III

    Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and ISO 21501-4.

  • MiniCapt® Mobile Microbial Air Sampler by Particle Measuring Systems (PMS)

    Microbial Air Sampler: MiniCapt® Mobile

    The innovative microbial air sampler. ISO 14698:2003 compliant

  • MiniCapt® Remote Air Sampler

    Remote Air Sampler: MiniCapt®

    Microbial remote air sampler uses a unique HEPA-filtered exhaust so it doesn’t contaminate your cleanroom.

  • Lasair® III 110 – 0.1 Micron Particle Counter

    The only true 0.1 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.

  • SamplerSight Software

    SamplerSight is a user-friendly software program for operating batch-based liquid particle measurement…

  • Particle Counter Software: DataAnalyst

    DataAnalyst Software helps you understand the data coming from your particle counter for an easy and low-cost way to manage data, including maintaining electronic records.

  • SamplerSight Pharma Particle Counter Software

    SamplerSight Particle Counter Software controls syringe operated samplers and collects data from a LiQuilaz particle sensor. Easy USP 788 calibration. 21 CFR Part 11 compliant.

  • Facility Net Facility Monitoring Software

    Facility Net Software provides a comprehensive environmental monitoring solution with real-time and historical data display for all…

Get a Quote

21 CFR Part 11 On Demand Webinar

From Paper to Paperless-Tackling the 21CFR11 Challenge 6/26/2019

Complying with the new 21 CFR Part 11 requirements present more challenging requirements. Bringing manufacturing processes and controls to a new level can appear simple in theory but provides many challenges in application. Using the example of a standard Data Management implementation, this presentation provides a variety of insights and solutions.

Watch Now

Ask a 21 CFR Part 11 Question

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Do you have a 21 CFR Part 11 or Data Integrity question? Submit your specific question below and one of our experts will respond shortly.

Ask Your Question

Frequently Asked Questions

  • Yes, if you’re using those scanned documents as your data, it is considered an electronic record and 21 CFR Part 11 applies.

    Managing scanned documents may be tricky when trying to have a consistent traceability of version history. In this case, electronic signature software such as Adobe Sign may help to ensure validation of
    document signatures and version traceability.

  • Yes, drug serialization will employ computerized systems which will need to comply with recent data integrity standards.

    Drug serialization will be enforced to guarantee traceability of product, meaning all associated operations, generated data, actions and information of the drug’s production process can be tracked using a single serial number. This can only be done with secure and compliant computerized systems in place.

  • These SOPs apply to computerized systems used in the company. GAMP category 3 requires less intervention, maintenance and validation efforts than a category 4 or 5 software. The SOP should not be related to a signal device/system, but generally enforced as part of the company’s quality standards.

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

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Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Software / Data Management
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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