Change Management

Engineering Change Order Overview

Working in an ISO certified environment, it is required to establish effective change control procedures in order to assure product quality and safety. using an electronic engineering change control systems is critical

Orcanos Engineering Change Order system (ECO)  electronically document and control ongoing change processes, such as SOP’s, design specs, drawing, part, form etc., from initiation, through approval, execution, follow-up, and e-signature approval.

Orcanos Engineering Change Order Benefits

• Satisfies 21 CFR Part 820
• End-to-end configurable workflow management
• Track ECO’s using predefined queries and dashboards KPI’s
• Easy customization of ECO attributes (Reason, Area, Initiator, Source…)
• Link ECO to relevant documents
• ECO traceability to CAPA, Risk, Non-conformance, R&D design changes
• Electronically sign ECO, base on predefined approval cycle
• Track related action items
• Automating Electronic Engineering Change Change Control
• Continuous Quality Improvement in FDA and ISO Environments
• Managing Change Control to Comply with FDA and EU Regulations