Engineering Change Notice Software (ECN) for Regulated Industries

Intellect’s Engineering Change Notice (ECN) Software helps manufacturers and life sciences companies streamline product and process changes. The ECN app centralizes change requests, approvals, and documentation in one secure, collaborative system—reducing risk and accelerating innovation.

Built on Intellect’s QMS AI platform, the ECN app empowers quality and engineering teams to manage change effectively.

Initiate, review, and approve changes using customizable workflows. Automatically trigger tasks, notifications, and escalations to ensure timely execution and prevent bottlenecks.

Track every detail from request to resolution with audit-ready records, digital signatures, and full version history. Ensure accountability and regulatory compliance at every stage.

Connect engineering, quality, and manufacturing teams through a shared platform. Keep stakeholders aligned with real-time updates and a single source of truth.

Capture critical information—such as affected products, departments, change classifications, and reasons—in one standardized form. Streamline decision-making and improve consistency.

Route ECNs to the appropriate approvers with electronic signatures and role-based permissions. Track who approved each change, when, and why.

Link ECNs to related NCRs, CAPAs, documents, or training events to ensure nothing falls through the cracks. Maintain traceability and a closed-loop approach to quality and compliance.

Track every detail from request to resolution with audit-ready records, digital signatures, and full version history. Ensure accountability and regulatory compliance at every stage.

Automatically document every step of the change process with versioned records, audit trails, and secure access controls—keeping you prepared for internal or regulatory audits.