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, and compliance forms can be tracked from the approval to the execution stage, all of which allow 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
- Configurable workflow management
- Track ECO status using predefined queries and KPIs
- Full customization of the ECO process
- Traceability to CAPA, Training, Non-Conformance, and R&D design changes
- An Electronic signature, based on a predefined approval process
- Ability to track related action items
Thanks to its flexible infrastructure, medical device companies can use Orcanos by adapting its system to fit their organizational procedures.
Control The Change
Use the ECO to add, change, or obsolete documents
Utilize Orcanos' user-friendly platform to manage, track, and control change effortlessly until completion.
What our client say about us
"Very good value for money, very helpful with preparations for audits"
Tsvika - System and Software QA Manager Medical Devices
I mainly used it for RISK management, and for PRD SRS and HRS documents requirements, including traceability to RISK. I also used it for Customer Complaints handling. Web based application is accesible from everywere by those who were defined by role. Everything is orgenized and traceable keeping changes history. It allows to keep implementation and testing coverage updated.
"Using ORCANOS for Medical Devices"
Gerd E - Lead System Architect
One database, one tool and user interface for requirement, risk , test, CAPA management etc. Item based! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent.
"My major tool for conformity."
Stephen - QA Manager
The simple and easy way of controlling documentation. Time saving and ease when undergoing audits by Notified Bodies. Traceability when it comes to CAPA and ECO's.
"I love the flexibility of Orcanos!"
I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom.
Technical Program Manager, Fio
The Orcanos medical ALM solution provides us with a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc.), risks management and traceability in a highly regulated environment.
Co-Founder, Mazor Robotics
Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…
…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…