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TDA-08: Technical Documentation Artifacts

TDA 7 — High Protect

Mechanisms exist to generate appropriate technical documentation artifacts for Technology Assets, Applications and/or Services (TAAS) in sufficient detail to demonstrate conformity with applicable statutory, regulatory and contractual compliance requirements.

Renumbered: Formerly TDA-22 in SCF 2025.4.

Code reused: In SCF 2025.4 and earlier, TDA-08 was Separation of Development, Testing and Operational Environments. That control is now TDA-15.1.

Control Question: Does the organization generate appropriate technical documentation artifacts for Technology Assets, Applications and/or Services (TAAS) in sufficient detail to demonstrate conformity with applicable statutory, regulatory and contractual compliance requirements?

General (2)
Framework Mapping Values
NIST AI 600-1 MP-4.1-003 MP-4.1-010 MS-2.9-001
SCF DPMP 2026 7.1
US (1)
Framework Mapping Values
USA California CCPA 2025 7123(c)(14)
EMEA (1)
Framework Mapping Values
EMEA EU AI Act Article 11.1 Article 11.2 Article 17.1(k) Article 23.1(b) Article 53.1(a)

Capability Maturity Model

Level 0 — Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 — Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 — Planned & Tracked

Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160). ▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 — Well Defined

Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners. ▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to generate appropriate technical documentation artifacts for Technology Assets, Applications and/or Services (TAAS) in sufficient detail to demonstrate conformity with applicable statutory, regulatory and contractual compliance requirements.

Level 4 — Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 — Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.

Assessment Objectives

  1. TDA-08_A01 appropriate technical documentation artifacts are generated for products and/or services in sufficient detail to demonstrate conformity with applicable statutory, regulatory and contractual compliance requirements.

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
E-TDA-17 System Design Documentation

Documented evidence of system design documentation.

Technology Design & Acquisition

Technology Recommendations

Micro/Small

  • Basic documentation (architecture, configuration, user guide) for developed products

Small

  • Documentation standards for developed systems (design, configuration, operations)

Medium

  • Technical documentation deliverables defined in the SDLC (architecture, security configuration, interfaces)
  • Documentation stored in controlled repository

Large

  • Technical documentation standards with security content requirements
  • Documentation reviewed at design and release gates
  • Developer contract deliverables

Enterprise

  • Enterprise technical documentation program covering internal and third-party developed products
  • Documentation management system with version control
  • Regulatory documentation requirements (e.g., EU CRA technical documentation)

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