Are Order Management Systems in Scope of 21 CFR Part 11?

Hi All, I did not see this question when a did a search of the topics. Does an Order Management System (OMS) require validation per 21 CFR Part 11? I understand that a Warehouse Management System (WMS) is in the scope of the regulation.

Yes. However, the scope is limited to pharmaceutical excipients and not pencils (office supplies). In addition it must be FIFO and able to count (1 = 1 and not 2…).

One small correction. I believe the new standards are First Expired First Out (FEFO). I believe this changed from FIFO recently.

A ‘blanket’ yes or no is not possible without knowing how you use the system, what records required under a predicate rule are maintained by the system, and if you electronically sign those records.

If, for example, your order comes in via the system and then you do the rest of fulfillment and tracking in a different system then it may not require validation.

It depends on the scope of the OMS, but most likely you would want it to be 21CFR part 11 compliant. While not explicit in CFR it will fall under ISO13485 section 7 product planning (I don’t have the latest reg so it might be different) and will be expected under CFR as well.