83% of ICH Q10 you already have
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) already covers about 83% of ICH Q10, leaving
1 of 6 controls as genuinely new work.
Already covered 2
Likely covered 3
New work 1
What is genuinely new work
Nothing in AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) reaches these. This is the list to scope.
ICH-Q10-Lifecycle-PharmDev-TechTransfer-CommMfg-ProductDiscontinuationICH Q10 - 4 Product Lifecycle Stages - Pharmaceutical Development + Technology Transfer + Commercial Manufacturing + Product Discontinuation
Show the 5 you already have
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ICH-Q10-Scope-PQS-ICH-Q8-Q9-Q11-Q12-ISO9001-GMP-CoordICH Q10 - Scope + Pharmaceutical Quality System (PQS) + ICH Q8/Q9/Q11/Q12 + ISO 9001 + GMP Coordination
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
How this is calculated
Already covered means a mapping runs from a control in AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) 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.
Try another pair ยท
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