GAMP 5 in the Age of Cloud ERP: What Changes in D365?

GAMP 5 was developed in an era of on-premises ERP systems where the validated organisation controlled the software, the infrastructure, and the change schedule. Cloud-based D365 fundamentally changes all three — and validation teams that apply traditional GAMP 5 approaches unchanged to D365 will find themselves over-validating some areas and under-validating others.

What Changes in the Cloud

• Supplier assessment: Microsoft is a Category 4/5 software supplier — your supplier assessment must cover Microsoft’s own quality management system, SLA commitments, and security controls
• Change control cadence: Microsoft releases two major waves per year plus continuous updates — your change control process must accommodate this without requiring full re-validation for every update
• Infrastructure qualification: IQ scope shifts from physical server qualification to cloud infrastructure configuration verification
• Data integrity: Backup, recovery, and data residency controls must be documented and tested within your validation package