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Particle Measuring Systems
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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

    Data Integrity

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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.

    read all

Relevant Products

  • FacilityPro® Processors

    Industrial control systems assure data integrity, process automation, simpicity of use, and data integration.

  • PharmaIntegrity

    PharmaIntegrity Data Integrity

    Creates a complete contamination monitoring solution for pharmaceutical manufacturers.

  • Cleanroom Particle Counter: Lasair® III

    Robust and reliable cleanroom particle counter meets the requirements of ISO 14644-1:2015, EU GMP Annex 1 and ISO 21501-4.

  • Microbial Air Sampler: MiniCapt® Mobile

    The innovative microbial air sampler. ISO 14698:2003 compliant

  • MiniCapt® Remote Microbial Air Sampler

    MiniCapt® Remote Microbial Air Sampler

    Uses a unique HEPA-filtered exhaust so it doesn’t contaminate the cleanroom.

  • Lasair® III 110 Airborne Particle Counter

    A true 0.10 micron particle counter, providing real-time measurement of yield-impacting particles with three configurations.

  • SamplerSight Software

    A user-friendly software program for operating batch-based liquid particle measurement systems. Provides a comprehensive view of the batch information.

  • 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 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

    Real-time and historical data display for all Particle Measuring Systems particle counters, molecular contamination monitors and various third-party products.

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

Ask a Question

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
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

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

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Contamination Control Papers
  • Particle College
  • Videos
  • Blog

About Us

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

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd
Boulder, CO 80301

T. +1-303-443-7100
T. +1-800-238-1801
F. +1-303-449-6870
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

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

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • PMS™ Knowledge Center
  • Particle College
  • Software / Data Management
  • Blog

About Us

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

Particle Measuring Systems- SG

Corporate Headquarters
5475 Airport Blvd
Boulder, CO 80301

T. +1-303-443-7100
T. +1-800-238-1801
F. +1-303-449-6870
E. [email protected]

Keep in touch! Receive industry news from us:

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