Hi @Leroy H ,
I am not familiar with GxP regulations and CFR 21 Part 11. this is a SQL Server forum, so I can only answer you from a SQL Server perspective.
First of all, SQL Server Express version has a lot of limitations, you may need to use Standard Edition or Enterprise Edition. In that case, you will need to purchase a license.
You can refer to this document to see the difference between the different Editions.
In addition, you need to purchase a license or have licensing-related questions, you can call 1-800-426-9400, Monday through Friday, 6:00 A.M. to 6:00 P.M. (Pacific Time) to speak directly to a Microsoft licensing specialist.
Best regards,
Seeya
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