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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.

  • Speaker

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems

    Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.

  • Speaker

    Maurizio Della Pietra, MPhys

    Associated Product Line Manager for Life Science Services, Particle Measuring Systems

    Maurizio collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. He also is the EMEA Field Application Specialist for Data Management and Analysis. He has a strong background in QA processes, validation of equipment, utilities, facilities, computer systems, data and production processes and aseptic production processes and statistical analysis of them.