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.
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.
