FDA 21 CFR Part 11

About FDA 21 CFR Part 11

FDA 21 CFR Part 11 was developed by the FDA in 1997. The rules change significantly how computer-generated data is to be stored and used, and aim to make electronic records comparable to a lab notebook in terms of providing a traceable record that is immutable.

This regulation requires the protection, accuracy, and quick retrieval of all records. Secured, computer-generated, time-stamped audit trails must be available to independently record the date and time of operator actions that modify the manufacturing process.

Meets 21 CFR Part 11 Requirements

UbiBot takes great pride in making sure the readings delivered by both our UbiBot and Ubitrack product lines are authentic, reliable, and confidential.

No data on UbiBot Platform can be accessed by unauthorized users. Username and password combinations are not shared between other users. UbiBot Platform is a secure cloud-based portal.

UbiBot securely and automatically posts all field changes to a separate database. The Audit Trail includes the field’s old value, new value, name of the user who made the change, and date and time. UbiBot not only stores the audit trail information but also allows for the information to be queried and help present the information to support a regulatory audit.

For more details, please kindly find attached docs. If you have more question, please feel free to voice out via [email protected]

UbiBot ® Software FDA 21 CFR Part 11 Compliance