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Is SQL EXPRESS GAMP5/GxP and CFR 21 Part 11 compliant?

Leroy H 20 Reputation points
2023-03-02T10:00:09.94+00:00

Hello everyone,

I am about to use SQL in a regulated environment which means that it has to be GMAP5/GxP & CFR 21 Part 11 compliant.

Is SQL EXPRESS GAMP5/GxP & CFR 21 Part 11 compliant or do I have to use the SQL Standard Verison?

Thank you in advance,

yours,

Leroy

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Answer accepted by question author

Seeya Xi-MSFT 16,756 Reputation points
2023-03-03T02:28:31.64+00:00

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.

https://learn.microsoft.com/en-us/sql/sql-server/editions-and-components-of-sql-server-2022?view=sql-server-ver16

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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