From Paper to Paperless-Tackling the 21CFR11 Challenge
Today, both the MHRA and FDA are highly focused on data integrity and discourage methods which manually record data. Modern data management systems provide secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes.
Complying with the new 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 including:
- Mitigating the risks of unplanned for steps.
- Fulfilling Data Integrity requirements.
- Leveraging the project to enhance process efficiency and Quality System Management compliance to recent regulations.