Join us for the Webinar "21 CFR Part 11 Compliant Instruments" ‐ Storing Electronic Records on Instruments without a PC? The live webinar* features presenters Bob McDowall and Christoph Jansen.
There are many pharmaceutical companies who integrate analytical instruments into a workflow according to 21 CFR Part 11 without a computer. They instead use firmware and internal memory.
In May 2020, there was a public "FDA form 483" issued that stated "firmware instruments" do not offer sufficient technical controls to avoid compliance issues. This was a clear warning to not implement this concept.
During the webinar we will discuss concepts and various workarounds, such as the usage of USB memory and why it should not be implemented in a regulated GMP laboratory.
We will discuss a business-friendly solution with savings potential that can help you on your journey of going digital in the laboratory. We will also explore replacing hybrid systems as requested by the WHO and other regulators.
*With recorded sections