Architecture Guide
15 min read
Architecting a 21 CFR Part 11 Validated Cloud Data Lakehouse on AWS & Databricks
The comprehensive validation and engineering blueprint for biopharma and medical device data teams. How to implement GxP compliance, immutable electronic audit trails, automated pipeline testing, and Computer Software Assurance (CSA) on AWS and Databricks.
Key Highlight: FDA 21 CFR Part 11 mandates closed-system validation, electronic signatures, time-stamped immutable audit trails, and strict access controls.
By Dr. Anita RoyRead Guide