21 CFR Part 211 — Current Good Manufacturing PracticevsEU Payment Services Directive (PSD2) – Under Review
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to EU Payment Services Directive (PSD2) – Under Review. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to EU Payment Services Directive (PSD2) – Under Review with 2% coverage across 1 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 56 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 1 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(3 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other EU Payment Services Directive (PSD2) – Under Review comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and EU Payment Services Directive (PSD2) – Under Review?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while EU Payment Services Directive (PSD2) – Under Review covers 27 controls. Direct mapping analysis identifies 1 overlapping controls (2% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct EU Payment Services Directive (PSD2) – Under Review equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and EU Payment Services Directive (PSD2) – Under Review?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 1 map directly to EU Payment Services Directive (PSD2) – Under Review controls — representing 2% coverage. The remaining 56 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to EU Payment Services Directive (PSD2) – Under Review?
56 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in EU Payment Services Directive (PSD2) – Under Review. The highest concentration of gaps is in Subpart J — Records and Reports with 9 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between 21 CFR Part 211 — Current Good Manufacturing Practice and EU Payment Services Directive (PSD2) – Under Review?
The domain with the highest gap count is Subpart J — Records and Reports (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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