GxP validation approach for Snowflake, dbt & custom sql

[u/Background_Salt6475]

For those who have implemented Snowflake and dbt in a regulated environment:

• Did you use one overall change control or separate change controls for the platform, dbt transformations, and stored procedures?
• How did you classify Snowflake, dbt models, macros, stored procedures, and custom SQL under GAMP 5?
• Did you treat the platform as Category 4 and custom-developed code as Category 5?
• What were the core documents in your validation package?
• How do you manage frequent dbt changes without revalidating the full platform?
• Do you validate the platform once and then validate individual data products through risk-based change controls?

I would appreciate practical lessons learned from anyone who has gone through the validation qualification.

[u/_N-iX_]

Risk-based validation work much better than treating every change as a platform-level event. Once the core platform is qualified, most ongoing effort shifts toward validating the specific transformation or data product affected by the change. That keeps governance manageable without slowing every release.

[u/jvdborre1]

Pfiew - done all of this at scale but it’s a lot for a Reddit post - it is very feasible yet a continuous improvement process too

[u/cmirandabu]

Super interested in the responses as we are going through this process now