Change Control

Companies that operate in an ISO-certified industry or environment are required to have effective engineering change control processes in place to guarantee product quality and safety. For this reason alone it is essential that these processes are documented and monitored in an efficient system-based workflow. 

Orcanos Engineering Change Order (ECO) software will digitally document and control ongoing change processes within the product lifecycle. Documents related to Standard Operating Procedures, product design specifications, drawings, part inventory, compliance forms can be tracked from the approval to the execution stage, all of which allows stakeholders to electronically sign-off on a specific requirement.

An electronic paper trail is always an effective way of tracking change. With that in mind, the Orcanos ECO module has the following benefits:

• Compliant with FDA CFR Part 820 (Quality System Regulation/Medical Device GMP)
• End-to-end configurable workflow management
• Ability to track ECOs using predefined queries and KPIs in a single dashboard
• Customization of ECO attributes such as reason, area, initiator and source
• Quick and easy ECO link to relevant documents in system
• Traceability for CAPA, Risk, Non-conformance and R&D design changes
• Electronic signature, based upon a predefined approval process
• Ability to track related action items 
• Automated Electronic Engineering Change and Change Control
• Continuous tracking of quality improvements in line with FDA and ISO requirements
• Management of Change Control to comply with FDA and European Union regulations