Manage complete Change Management lifecycle
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
ORCANOS | Medical infrastructure
Using ORCANOS flexible infrastructure, allows you to customise your ECO (Engineering Change Order) form, customise attributes, and most importantly, trace your ECO to other work items in Orcanos Medical, such as FMEA risk, CAPA, Complaint, or R&D, such as requirements.
ORCANOS e-Forms infrastructure also allows you to manage the derived action items from the ECR/ECO processes and control the execution of the related action items.