How ELTON Supports CAPA for Cybersecurity Vulnerabilities

Corrective and Preventive Action (CAPA) is a core requirement under the FDA’s Quality System Regulation, specifically 21 CFR 820.100 (Corrective and Preventive Action) and 21 CFR 820.198 (Complaint Files). It applies directly to cybersecurity vulnerabilities, whether discovered internally (e.g., testing, code review, SBOM analysis) or externally (e.g., coordinated disclosures, customer complaints, field service reports). In addition to these regulatory requirements, the FDA’s 2016 Postmarket Management of Cybersecurity in Medical Devices Guidance emphasizes the use of CAPA systems to manage postmarket vulnerabilities that present uncontrolled risk.

ELTON was built to help manufacturers fulfill these obligations specifically for cybersecurity-related findings, ensuring they are addressed in a defensible, traceable, and system-aware way.

Traceability Across the Lifecycle for Cybersecurity CAPA

When a cybersecurity vulnerability is identified—whether through internal testing or an external report—ELTON captures and links it to the affected system components, device version, and software architecture. The platform records the discovery method, triage date, scoring rationale, and follow-up actions. This enables manufacturers to fulfill 21 CFR 820.198 by maintaining complaint records related to cybersecurity issues and ensures that every corrective or preventive action required under 21 CFR 820.100 is traceable to its root cause and outcome.

Architecture-Aware Corrective Action

Effective corrective action in the cybersecurity domain requires understanding system context, not just vulnerability presence. ELTON evaluates the exploitability and downstream impact of each finding based on the device’s architecture, interfaces, and trust boundaries. If remediation is warranted, ELTON links the patch or control to the original finding and records whether the mitigation successfully reduced the system-level risk. If no remediation is needed, ELTON captures the justification, aligned with the FDA’s 2016 postmarket guidance, which allows manufacturers to justify risk when it is demonstrably controlled.

Preventive Action Informed by Real Data

Beyond corrective steps, ELTON helps teams take preventive action by identifying trends across products and suppliers—recurring components, insecure configurations, or systemic design weaknesses. These insights enable preventive updates to design, supplier controls, or internal processes, and ensure that these updates are logged and linked to the originating cybersecurity issue. This aligns with the FDA’s expectations in the 2016 guidance for continuously assessing the exploitability and severity of vulnerabilities over time and proactively addressing emerging risks before they lead to patient harm or system compromise.

Purpose-Built for Regulatory-Grade Cybersecurity CAPA

The FDA expects manufacturers to maintain a robust cybersecurity CAPA process that is both ongoing and defensible. ELTON is purpose-built to support this need by managing the full lifecycle of cybersecurity-related CAPA activities—whether vulnerabilities are identified internally or reported externally. All actions are recorded in a format that can be shared during audits, reviewed internally, or submitted with premarket documentation or postmarket filings.

By aligning with 21 CFR 820.100, 21 CFR 820.198, and the FDA’s 2016 postmarket cybersecurity guidance, ELTON ensures manufacturers can meet regulatory expectations with clarity, consistency, and confidence.