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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.

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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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