Skip to main content

TDA-04: Documentation Requirements

TDA 8 — High Protect

Mechanisms exist to obtain, protect and distribute administrator documentation for Technology Assets, Applications and/or Services (TAAS) that describe: (1) Secure configuration, installation and operation of the TAAS; (2) Effective use and maintenance of security features/functions; and (3) Known vulnerabilities regarding configuration and use of administrative (e.g., privileged) functions.

Control Question: Does the organization obtain, protect and distribute administrator documentation for Technology Assets, Applications and/or Services (TAAS) that describe: (1) Secure configuration, installation and operation of the TAAS; (2) Effective use and maintenance of security features/functions; and (3) Known vulnerabilities regarding configuration and use of administrative (e.g., privileged) functions?

General (32)
Framework Mapping Values
CSA CCM 4 IVS-08
GovRAMP Low SA-05
GovRAMP Low+ SA-05
GovRAMP Moderate SA-05
GovRAMP High SA-05
IEC TR 60601-4-5 2021 6(a) 6(b) 6(c) 6(d) 6(e) 6(f) 6(g) 6(h) 6(i) 6(j) 6(k) 6(l) 6(m) 6(n) 6(o) 6(p) 6(q) 6(r) 6(s) 6(t) 6(u) 6(v)
ISO/SAE 21434 2021 RQ-06-11 RQ-06-12 RQ-06-14 RQ-06-16 RQ-06-17 RQ-06-18 RQ-06-21 RQ-06-21.c RQ-06-22
ISO 42001 2023 A.6.2.7 A.6.2.8
NIST AI 100-1 (AI RMF) 1.0 GOVERN 4.2
NIST 800-53 R4 SA-5
NIST 800-53 R4 (low) SA-5
NIST 800-53 R4 (moderate) SA-5
NIST 800-53 R4 (high) SA-5
NIST 800-53 R5 (source) SA-5
NIST 800-53B R5 (low) (source) SA-5
NIST 800-53B R5 (moderate) (source) SA-5
NIST 800-53B R5 (high) (source) SA-5
NIST 800-82 R3 LOW OT Overlay SA-5
NIST 800-82 R3 MODERATE OT Overlay SA-5
NIST 800-82 R3 HIGH OT Overlay SA-5
NIST 800-161 R1 CM-8(10) SA-5
NIST 800-161 R1 C-SCRM Baseline SA-5
NIST 800-161 R1 Level 3 SA-5
NIST 800-171 R2 (source) NFO-SA-5
NIST 800-218 PO.3.3 PS.3.2 RV.1.1
OWASP Top 10 2021 A01:2021 A02:2021 A03:2021 A04:2021 A05:2021 A06:2021 A07:2021 A08:2021 A09:2021 A10:2021
UL 2900-1 2017 4.1 5.1 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9
SCF CORE Mergers, Acquisitions & Divestitures (MA&D) TDA-04
SCF CORE ESP Level 1 Foundational TDA-04
SCF CORE ESP Level 2 Critical Infrastructure TDA-04
SCF CORE ESP Level 3 Advanced Threats TDA-04
SCF CORE AI Model Deployment TDA-04
US (17)
EMEA (5)
Framework Mapping Values
EMEA EU AI Act 11.1
EMEA EU EBA GL/2019/04 3.6.2(73)
EMEA Germany C5 2020 DEV-02
EMEA Israel CDMO 1.0 17.6 17.10
EMEA Saudi Arabia OTCC-1 2022 1-1-2
APAC (3)
Framework Mapping Values
APAC Australia ISM June 2024 ISM-1798
APAC New Zealand NZISM 3.6 3.4.10.C.01 3.4.10.C.02
APAC Singapore MAS TRM 2021 6.1.4

Capability Maturity Model

Level 0 — Not Performed

There is no evidence of a capability to obtain, protect and distribute administrator documentation for Technology Assets, Applications and/or Services (TAAS) that describe: (1) Secure configuration, installation and operation of the TAAS; (2) Effective use and maintenance of security features/functions; and (3) Known vulnerabilities regarding configuration and use of administrative (e.g., privileged) functions.

Level 1 — Performed Informally

C|P-CMM1 is N/A, since a structured process is required to obtain, protect and distribute administrator documentation for Technology Assets, Applications and/or Services (TAAS) that describe: (1) Secure configuration, installation and operation of the TAAS; (2) Effective use and maintenance of security features/functions; and (3) Known vulnerabilities regarding configuration and use of administrative (e.g., privileged) functions.

Level 2 — Planned & Tracked

Technology Development & Acquisition (TDA) efforts are requirements-driven and governed at a local/regional level, but are not consistent across the organization. CMM Level 2 control maturity would reasonably expect all, or at least most, the following criteria to exist:

  • Development and acquisition management is decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
  • IT/cybersecurity personnel identify cybersecurity and data protection controls to address applicable statutory, regulatory and contractual requirements for technology development and acquisition management.
  • IT/cybersecurity personnel implement secure practices to protect the confidentiality, integrity, availability and safety of the organization's technology assets, data and network(s).
  • Secure development practices mostly conform to industry-recognized standards for secure engineering (e.g., OWASP, NIST SP 800-218, NIST SP 800-160, etc.).
  • Procurement practices require third-party developers of Technology Assets, Applications and/or Services (TAAS), system components or services to follow secure engineering practices.
  • A Project Management Office (PMO), or project management function, enables the implementation of cybersecurity and data privacy-related resource planning controls across the System Development Lifecycle (SDLC) for all high-value projects.
Level 3 — Well Defined

Technology Development & Acquisition (TDA) efforts are standardized across the organization and centrally managed, where technically feasible, to ensure consistency. CMM Level 3 control maturity would reasonably expect all, or at least most, the following criteria to exist: o Provides governance oversight for the implementation of applicable statutory, regulatory and contractual cybersecurity and data protection controls to protect the confidentiality, integrity, availability and safety of the organization's applications, Technology Assets, Applications and/or Services (TAAS), services and data for technology development and acquisition. o Ensures the Information Assurance Program (IAP) evaluates applicable cybersecurity and data protection controls as part of “business as usual” pre-production testing. o Operates the Cybersecurity Supply Chain Risk Management (C-SCRM) program to identify and mitigate supply chain-related risks and threats.

  • Secure development practices conform to industry-recognized standards for secure engineering (e.g., OWASP, NIST SP 800-218, NIST SP 800-160, etc.).
  • A procurement team, or similar function, ensures that third party development and/ or acquisitions meet, or exceed, the organization's business, cybersecurity and data privacy requirements to have secure and resilient Technology Assets, Applications and/or Services (TAAS), applications, services and processes.
  • A Software Assurance Maturity Model (SAMM) governs a secure development lifecycle for the development of Technology Assets, Applications and/or Services (TAAS), applications and services.
  • Administrative processes exist and technologies are configured to implement secure configuration settings by default to reduce the likelihood of software being deployed with weak security settings, putting the asset at a greater risk of compromise.
  • An IT Asset Management (ITAM) function, or similar function, categorizes devices according to the data the asset stores, transmits and/ or processes and applies the appropriate technology controls to protect the asset and data.
  • A formal Change Management (CM) program help to ensure that no unauthorized changes are made, all changes are documented, services are not disrupted and resources are used efficiently.
  • A Governance, Risk & Compliance (GRC) function, or similar function;
  • A Project Management Office (PMO), or project management function, enables IAP pre-production testing of cybersecurity and data protection controls as part of the organization's established project management processes.
Level 4 — Quantitatively Controlled

Technology Development & Acquisition (TDA) efforts are metrics driven and provide sufficient management insight (based on a quantitative understanding of process capabilities) to predict optimal performance, ensure continued operations and identify areas for improvement. In addition to CMM Level 3 criteria, CMM Level 4 control maturity would reasonably expect all, or at least most, the following criteria to exist:

  • Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
  • Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
  • Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
  • Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
  • Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
  • Both business and technical stakeholders are involved in reviewing and approving proposed changes.
Level 5 — Continuously Improving

See C|P-CMM4. There are no defined C|P-CMM5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to obtain, protect and distribute administrator documentation for Technology Assets, Applications and/or Services (TAAS) that describe: (1) Secure configuration, installation and operation of the TAAS; (2) Effective use and maintenance of security features/functions; and (3) Known vulnerabilities regarding configuration and use of administrative (e.g., privileged) functions.

Assessment Objectives

  1. TDA-04_A01 administrator documentation for the system, system component or system service that describes the secure configuration of the system, component or service is obtained or developed.
  2. TDA-04_A02 administrator documentation for the system, system component or system service that describes the secure installation of the system, component or service is obtained or developed.
  3. TDA-04_A03 administrator documentation for the system, system component or system service that describes the secure operation of the system, component or service is obtained or developed.
  4. TDA-04_A04 administrator documentation for the system, system component or system service that describes the effective use of cybersecurity / data privacy functions and mechanisms is obtained or developed.
  5. TDA-04_A05 administrator documentation for the system, system component or system service that describes the effective maintenance of cybersecurity / data privacy functions and mechanisms is obtained or developed.
  6. TDA-04_A06 user documentation for the system, system component or system service that describes user-accessible cybersecurity / data privacy functions and mechanisms is obtained or developed.
  7. TDA-04_A07 user documentation for the system, system component or system service that describes how to effectively use those (user-accessible cybersecurity / data privacy) functions and mechanisms is obtained or developed.
  8. TDA-04_A08 user documentation for the system, system component or system service that describes methods for user interaction, which enable individuals to use the system, component or service in a more secure manner is obtained or developed.
  9. TDA-04_A09 user documentation for the system, system component or system service that describes methods for user interaction, which enable individuals to use the system, component or service to protect individual privacy is obtained or developed.
  10. TDA-04_A10 user documentation for the system, system component or system service that describes user responsibilities for maintaining the cybersecurity / data privacy of the system, component or service is obtained or developed.
  11. TDA-04_A11 actions to take when system, system component or system service documentation is either unavailable or nonexistent are defined.
  12. TDA-04_A12 personnel or roles to distribute system documentation to is/are defined.
  13. TDA-04_A13 administrator documentation for the system, system component or system service that describes known vulnerabilities regarding the configuration of administrative or privileged functions is obtained or developed.
  14. TDA-04_A14 administrator documentation for the system, system component or system service that describes known vulnerabilities regarding the use of administrative or privileged functions is obtained or developed.
  15. TDA-04_A15 attempts to obtain system, system component or system service documentation when such documentation is either unavailable or nonexistent is documented.
  16. TDA-04_A16 after attempts to obtain system, system component or system service documentation when such documentation is either unavailable or nonexistent, actions are taken in response.
  17. TDA-04_A17 documentation is distributed to personnel or roles.

Evidence Requirements

E-CPL-06 Manufacturer Disclosure Statement for Medical Device Security (MDS2)

Documented Manufacturer Disclosure Statement for Medical Device Security (MDS2) that communicates information about medical device cybersecurity & data privacy characteristics to current device owners and potential buyers. [note MDS2 is specific to medical device manufacturers]

Compliance
E-TDA-06 Multi Patient Harm View (MPHV)

Documented evidence of a description of a Multi Patient Harm View (MPHV) that explains how the device / system defends against and/or responds to attacks with the potential to harm multiple patients. [note MPHV is specific to medical device manufacturers]

Technology Design & Acquisition
E-TDA-10 Security Use Case View (SUCV)

Documented evidence of diagrams, with explanatory text, describing various security scenarios in each of the operational and clinical functionality states of the system and how the system addresses each scenario architecturally. [note SUCV is specific to medical device manufacturers]

Technology Design & Acquisition

Technology Recommendations

Micro/Small

  • Cybersecurity Supply Chain Risk Management (C-SCRM) program
  • Product / project management

Small

  • Cybersecurity Supply Chain Risk Management (C-SCRM) program
  • Product / project management

Medium

  • Cybersecurity Supply Chain Risk Management (C-SCRM) program
  • Product / project management

Large

  • Cybersecurity Supply Chain Risk Management (C-SCRM) program
  • Product / project management

Enterprise

  • Cybersecurity Supply Chain Risk Management (C-SCRM) program
  • Product / project management

The Secure Controls Framework (SCF) is maintained by SCF Council. Use of SCF content is subject to the SCF Terms & Conditions.

Manage this control in SCF Connect

Track implementation status, collect evidence, and map controls to your compliance frameworks automatically.