Framework overlap

Does FDA 21 CFR Part 11 cover PCI SSF?

You hold FDA 21 CFR Part 11 and have been told to do PCI SSF. Here is how much overlaps, control by control.

33% of PCI SSF you already have

FDA 21 CFR Part 11 already covers about 33% of PCI SSF, leaving 33 of 49 controls as genuinely new work.

Already covered 0 Likely covered 16 New work 33

No control in FDA 21 CFR Part 11 maps directly to one in PCI SSF. 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 FDA 21 CFR Part 11 reaches these. This is the list to scope.

PCI-SSF-01
Information security program management
PCI-SSF-02
Board and management oversight
PCI-SSF-04
Security policy framework
PCI-SSF-13
Third-party dependency management
PCI-SSF-18
Ongoing monitoring and assessment
PCI-SSF-19
Concentration risk management
PCI-SSF-20
Exit strategy and transition planning
PCI-SSF-22
Incident response and containment
PCI-SSF-23
Regulatory reporting requirements
SSLC-1.1
Security Responsibility and Resources
SSLC-10.1
Software Integrity
SSLC-11.1
Stakeholder Communication
SSLC-12.1
Software Update Integrity and Verification
SSLC-2.1
Software Security Policy
SSLC-3.1
Software Security Personnel Skills
SSLC-4.1
Threat Identification and Risk Mitigation
SSLC-5.1
Software Design Security
SSLC-6.1
Secure Coding Practices
SSLC-7.1
Security Testing
SSLC-8.1
Vulnerability Disclosure and Response
SSLC-9.1
Change Management
SSS-1.1
Critical Asset Identification
SSS-1.2
Critical Asset Protection
SSS-10.1
Sensitive Authentication Data (Module A)
SSS-11.1
Terminal Software Module Requirements (Module B)
SSS-2.1
Sensitive Data Inventory and Protection
SSS-3.1
Critical Asset Cryptographic Protection
SSS-4.1
Authentication and Access Control
SSS-5.1
Attack Detection
SSS-6.1
Threat and Vulnerability Management
SSS-7.1
Secure Software Updates
SSS-8.1
Vendor Security Guidance
SSS-9.1
Account-Data Protection (Module A)
Show the 16 you already have
PCI-SSF-03
Risk appetite and tolerance for IT risk
PCI-SSF-05
Roles and responsibilities definition
PCI-SSF-06
Network security and segmentation
PCI-SSF-07
Endpoint protection and detection
PCI-SSF-08
Application security controls
PCI-SSF-09
Encryption and key management
PCI-SSF-10
Secure configuration standards
PCI-SSF-11
Business continuity planning and testing
PCI-SSF-12
Disaster recovery procedures
PCI-SSF-14
Critical service identification
PCI-SSF-15
Communication and escalation procedures
PCI-SSF-16
Due diligence and onboarding
PCI-SSF-17
Contractual security requirements
PCI-SSF-21
Incident detection and classification
PCI-SSF-24
Customer notification procedures
PCI-SSF-25
Post-incident review and improvement

How this is calculated

Already covered means a mapping runs from a control in FDA 21 CFR Part 11 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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