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In regulated environments, the Assess phase is where the right decisions prevent downstream compliance risk.
AWS programs and partners accelerate execution; internal GxP SMEs own classification, validation scope, and acceptance.
Assess regulated workloads for AWS — without breaking validation
Risk-based, GxP-aligned approach informed by CSV, IQ/OQ/PQ, and AWS shared responsibility.
GxP Validation Lens
- Risk-based (CSV-aligned)
- IQ / OQ / PQ impact assessed
- 21 CFR Part 11 + data integrity