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LSOPS07-BP02 Isolate GxP data from non-GxP data - Life Sciences Lens

LSOPS07-BP02 Isolate GxP data from non-GxP data

Take steps to isolate and segment GxP data from non-GxP data. In conjunction with the recommendations around data discovery and classification, separate GxP data so the organization can implement the necessary technical and administrative controls.

Desired outcome: Demonstrable division between GxP and non-GxP data.

Common anti-patterns:

  • Granting access at a workload level grants access to the data, GxP and non-GxP.

  • Retaining logs that are adjacent to GxP relevant metadata.

  • Including GxP data in logs.

Level of risk exposed if this best practice is not established: High

Implementation guidance

Incorporate system separation, including table and row-level access controls.

Implementation steps

  1. Foster system separation though architecture design and deployment.  Create distinct datastores (like Amazon S3 and Amazon RDS) for GxP data.

  2. Implement table and row-level access controls through application logic.

  3. Apply AWS Lake Formation rules for consistent control to data sets.

  4. Produce evidence of verification of access controls.

Resources

Related tools: