Orcanos

What do you like best?

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. Without knowing about Covid as we took the decision, this feature became more important than foreseen. Zero efforts were needed to work from home.

Good discussions with ORCANOS about new features or improvements.

What do you dislike?

Data response times are sometimes long as we handle several thousands of items.

Generating "nice" MS-Word files with special formated tables and using own templates could be improved. But this is probably a typical MS-Word issue as the html view and output is fine.

As we have a very complex system of systems structure (e.g. a CT scanner is just a sub-component), the management of this complex hirachy is by nature a challenge. The number of project hirachies and their management could be improved.

What problems are you solving with the product? What benefits have you realized?

We were looking for an "all in one" and 100% cloud-based tool (remote work from anywhere) with as low as possible efforts for the tool administration itself, as far as possible self-explaining to optimize training efforts. Further a tool, which covers all the needs for medical devices. This is all covered and we manage thousands of items with Orcanos. Actually, we use it "only" for risk- requirement- and test-management as we already had before a DMS (Document Management System) in place.

Best would be to use Orcanos as management tool for the overall product lifecycle, from first ideas (business requirements) to PMS, including as far as possible the 13485 requirements like non-conformities, complaint handling and CAPA management, DMS etc.