As the EU Cyber Resilience Act (CRA) Article 14 reporting obligations take effect on September 11, 2026, manufacturers of products with digital elements face the urgent need to comply with stringent cybersecurity requirements. Visure Solutions has announced a new compliance solution designed to address every facet of the CRA, from essential requirements in Annex I to 10-year documentation retention under Annex VII.
The CRA is not merely a paperwork exercise but a structured engineering process that spans the entire product lifecycle. Fernando Valera, CTO at Visure Solutions, emphasizes that treating compliance as a documentation task will leave manufacturers unable to respond to incidents within the mandated 24-hour window, reproduce historical baselines for audits, or demonstrate governed processes to notified bodies.
Visure's ALM platform offers an integrated CRA compliance workflow, replacing fragmented tools with a unified environment. Key features include end-to-end traceability that maps each CRA requirement to design decisions and verified tests, with automatic suspect-link flags on any upstream change. This live traceability is crucial for maintaining evidence integrity.
When a CVE is reported, the platform's blast-radius analysis instantly identifies affected requirements, baselines, and product versions, enabling manufacturers to meet Article 14's strict deadlines of 24 hours, 72 hours, and 14 days. The system tracks these SLA deadlines in real time, ensuring timely reporting to ENISA and CSIRTs.
The solution also facilitates the generation of technical audit packs on demand. Annex VII evidence packs are built continuously from engineering work and can be exported from signed baselines in minutes via Word or ReqIF. This ensures that manufacturers can provide comprehensive documentation to market surveillance authorities without delay.
Governed review workflows ensure that requirements pass through approval processes before entering electronically signed, immutable baselines. These baselines can be fully restored years later, meeting the 10-year retention requirement and supporting any market surveillance request.
Visure's AI engine, Vivia, assists in generating CRA-aligned requirement drafts from Annex I clauses, significantly reducing the time required. Importantly, Vivia operates on-premise, ensuring zero data leaves the customer environment, and human sign-off is mandatory before any baseline entry.
“As manufacturers move toward operational CRA compliance, Visure provides the engineering foundation required to meet every obligation as a governed, repeatable process, not a documentation exercise,” said Moustapha Tadlaoui, CEO at Visure Solutions. “Live traceability. Signed baselines. On-premise AI. All in one platform.”
To assist manufacturers in navigating these requirements, Visure is hosting a webinar on September 24, 2026, titled “Ensuring Cyber Resilience Act (CRA) Compliance Across the Product Lifecycle.” The session will cover Article 14 response workflows, Annex VII evidence pack generation, and AI requirements generation with Vivia. Registration is available at Visure's webinar page.
Visure Solutions is a leading provider of AI-driven requirements management and ALM solutions, assisting regulated manufacturers in improving quality and ensuring compliance across safety-critical industries. More information can be found at www.visuresolutions.com.
