ECO

Orcanos Engineering Change Order (ECO) is a change control and quality management software designed for regulated industries, including medical device companies and pharmaceutical manufacturers. It provides a centralized platform to digitally document, track, and control change processes across the product lifecycle, replacing manual, paper-based systems that introduce risk, delays, and compliance gaps.

The software integrates change management with quality and engineering workflows, giving teams visibility into every stage of a change from initiation through completion. It is intended for organizations that need to maintain compliance with regulatory requirements while coordinating approvals, documentation, and training across multiple stakeholders.

Core Capabilities

• Manage changes across documents, design controls, and quality records within a single platform.
• Link changes to quality events such as audits or complaints to support continuous improvement documentation.
• Add, modify, or obsolete documents using the ECO process.
• Automate notifications, approvals, and training workflows to keep teams aligned throughout the change process.
• Track every step of the change process with real-time updates and comprehensive audit trails.

Key Features

• ECO Tracking: Monitors each step of the change process from start to completion.
• Electronic Signature Support: Provides secure, compliant electronic approvals.
• Custom Workflows: Allows configuration to match specific business requirements.
• Automated Documentation: Supports audit readiness through automated record-keeping.

Reported Benefits

• Efficiency: Reduces time and effort associated with manual change management processes.
• Transparency: Provides real-time visibility and a full audit trail at every stage of a change.
• Compliance: Supports audit preparedness through automated documentation and electronic approvals.
• Collaboration: Centralizes tools and information to bring stakeholders together across the change process.

Orcanos ECO is positioned as part of a broader integrated quality and engineering management platform. It is used by regulated industries, with particular applicability to medical device and pharmaceutical companies that require structured change control processes aligned with quality management standards.