7% of 21 CFR Part 58 you already have
Azure Security Benchmark already covers about 7% of 21 CFR Part 58, leaving
27 of 29 controls as genuinely new work.
Already covered 0
Likely covered 2
New work 27
No control in Azure Security Benchmark
maps directly to one in 21 CFR Part 58. 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 Azure Security Benchmark reaches these. This is the list to scope.
58.10Applicability to Grants and Contracts
58.105Test and Control Article Characterization
58.107Test and Control Article Handling
58.113Mixtures of Articles with Carriers
58.130Conduct of a Nonclinical Laboratory Study
58.15Inspection of Testing Facility
58.185Reporting of Nonclinical Laboratory Study Results
58.190Storage and Retrieval of Records and Data
58.195Retention of Records
58.200Purpose of Disqualification
58.202Grounds for Disqualification
58.206Final Order on Disqualification
58.219Reinstatement of Disqualified Facility
58.31Testing Facility Management
58.35Quality Assurance Unit
58.41General Facility Requirements
58.45Animal Supply Facilities
58.47Laboratory Operation Areas
58.51Specimen and Data Storage Facilities
58.63Maintenance and Calibration of Equipment
58.81Standard Operating Procedures
58.83Reagents and Solutions
Show the 2 you already have
58.43Animal Care Facilities
58.49Laboratory Operation Areas
How this is calculated
Already covered means a mapping runs from a control in Azure Security Benchmark 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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