Title 21 CFR Part 11 Compliance

When developing and building electronic devices intended to be used for medical purposes, extensive records need to be kept. The United States Food and Drug Administration regulations specify the criteria under which electronic records are considered equivalent to paper records. The regulations are commonly called "Title 21 CFR Part 11", as they are part of the Code of Federal Regulations.

The requirements are very strict: a secure, computer-generated, time-stamped audit trail is required and all records need to be protected against alteration.

Lot tracking (control) is required, to provide tracking ability in two directions:

• Find production batches based on a manufacturer/distributor lot number, so that possibly faulty devices can be found and recalled.
• Find manufacturer/distributor lot number based on a device serial number, so that parts can be tracked to their source.

These requirements are difficult to meet for hardware startups that design and build medical devices. There are very few inventory tracking systems that claim to be compliant with Title 21 CFR Part 11, and even fewer that actually meet all the requirements.

If you need CFR Part 11 compliance, please contact PartsBox.