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On Demand 21CFR Part 11 Webinar

OnDemand Webinar: Tackling the 21CFR11 Challenge: From Paper to Paperless

Both the MHRA and FDA are highly focused on data integrity and discourage methods which manually record data. Modern paperless data management systems provide secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes.

21CFR11 data integrity

FDA Warning Letters by year related to Data Integrity

Complying with the new 21cfr11 paperless 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 21CFR11 on-demand webinar provides a variety of insights on going paperless including:

  • Mitigating the risks of unplanned steps
  • Fulfilling Data Integrity requirements
  • Leveraging the project to enhance process efficiency and Quality System Management compliance to recent regulations

In need of a paperless solution? Particle Measuring Systems has a variety of options from particle counter product-specific items such as DataAnalyst software to cleanroom data management option PharmaIntegrity.

Register for the Webinar today, watch when you have time.

More 21CFR Part 11 Information

Data Quality – The Journey of Cleanroom Data Management Life Cycle

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

21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

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

 

 

Complete this form to access the webinar:

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5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
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Keep in touch! Receive industry news from us:

Products

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

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP<788> Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Environmental Monitoring Solutions for Your Contamination Control
  • 21CFR 11

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 Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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