When conducting cell therapy research or manufacturing process development, there is an emphasis on making sure the technical components are accurate. It is critical to ensure the science works, but it is equally important to maintain complete and accurate electronic records to allow for smooth regulatory submission.
In this 30 minute webinar, experts will share insights to help you better understand how electronic records and the requirements for 21 CFR Part 11 compliance are related. They will also discuss compliance for cell therapy instruments through SAE (security, audit, and signature) software. Having a system in place early during process development for electronic records and electronic signatures could save you time and effort as you transition to manufacturing.
Topics in this webinar include:
- A short overview of 21 CFR Part 11
- Understanding options for instrument software for cell therapy development and manufacturing processes
- Introduction to SAE (security, audit and e-signature) software
- Learn about the CTS Rotea SAE software for cell processing using the CTS Rotea Counterflow Centrifugation System