Framework overlap

Does NIST SP 1800-32 cover GAMP 5?

You hold NIST SP 1800-32 and have been told to do GAMP 5. Here is how much overlaps, control by control.

36% of GAMP 5 you already have

NIST SP 1800-32 already covers about 36% of GAMP 5, leaving 7 of 11 controls as genuinely new work.

Already covered 0 Likely covered 4 New work 7

No control in NIST SP 1800-32 maps directly to one in GAMP 5. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in NIST SP 1800-32 reaches these. This is the list to scope.

GAMP5-CrossMapping-NIST-ISO
Crosswalk to NIST CSF, ISO 27001/27017, ISO 13485 (Medical Devices) and ITIL
GAMP5-Crosswalk-ICH-FDA-EMA-MHRA
Crosswalk to ICH Q9/Q10, FDA Part 11, EU Annex 11, MHRA Data Integrity and Sectoral Standards
GAMP5-DataIntegrity-Part11-Annex11
Data Integrity (ALCOA+), 21 CFR Part 11 + EU Annex 11 + Electronic Records
GAMP5-ISPE-Status-Copyright-Coordination
ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates
GAMP5-Implementation-Roadmap
GAMP 5 Implementation Roadmap - Organizational Roles, Training and Tooling
GAMP5-Software-Categories
5 Software Categories (Appendix M4) - Infrastructure, Non-Configured, Configured, Custom
GAMP5-Status-2024-2025-CSA-AI
GAMP 5 Status, FDA CSA Final Guidance and AI/ML in Pharma 2024-2025
Show the 4 you already have
GAMP5-2nd-Edition-AI-Cloud-Agile-CSA
2nd Edition (2022) - AI/ML, Cloud, Agile, DevOps and Computer Software Assurance (CSA)
GAMP5-Lifecycle-VModel-URS-FS-DS-IQOQPQ
V-Model Lifecycle - URS + FS + DS + IQ + OQ + PQ + Traceability
GAMP5-Risk-CriticalThinking
Risk-Based Approach, Critical Thinking and 5 Key Concepts
GAMP5-Supplier-Operations-Change-Periodic
Supplier Assessment, Operational Phase, Change Control and Periodic Review

How this is calculated

Already covered means a mapping runs from a control in NIST SP 1800-32 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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