We bring a Secured, Robust, and Simple platform for compliance management that integrates ALM & QMS into faster and smoother processes. When ALM & QMS processes are managed in one place, it allows you to trace artifacts and the interconnection of cross-organizational processes.
In this holistic approach, time to market can be shortened, costs can be reduced, and frustration would be prevented.
This first-to-market holistic approach enables companies to meet the standards using one system that benefits both R&D and the Quality team.
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Our QMS brings all the standard capabilities every QMS has, but it is 100% adaptive. In other words, you can choose to follow the A best practices Orcanos provides or take it your own way and save time on onboarding by defining your own workflows and processes.
You don't have to worry; the regulation is already inside.
Orcanos provides an entire ALM and quality management to ensure that your products meet and surpass regulatory compliance standards such as ISO 13485, 21 CFR Part 11, ISO 14971, IEC 62304, and more.It is the only software that integrates your design control, quality management, and regulatory compliance in a single system, using predefined templates to meet industry standards.
Meet industry standards through continuous monitoring in less time, avoid the need to explain expectations to R&D, and make your quality event a streamlined process seamlessly connecting departments.
Allows you to plan, approve, trace, and validate requirements, connect risk items to design artifacts for mitigation, manage audits and ensure regulatory compliance, and export ready-to-submit documents and reports into a Microsoft Office environment.
Meet industry standards through continuous monitoring in less time, avoid the need to explain expectations to R&D, and make your quality event a streamlined process seamlessly connecting departments.
Allows you to plan, approve, trace, and validate requirements, connect risk items to design artifacts for mitigation, manage audits and ensure regulatory compliance, and export ready-to-submit documents and reports into a Microsoft Office environment.
No more (hand) paperwork. Yes, you read it right.
With Orcanos, generating and controlling any document is easier with one click. Using the latest data, generate audit and submission-ready documents using the Document generator. Then, simply review, approve, sign, distribute, and manage training using the Document Control Module.
Be sure your documents are genuine, authentic, and based on the up-to-date data, then sign off and let Orcanos revise, control, and distribute to relevant stakeholders for training and acknowledgment. And all is in only one place, monitoring and preventing human errors.
Let yourself be an engineer and not a writer. Generate ready-for-submission documents easily from your database.
Be sure your documents are genuine, authentic, and based on the up-to-date data, then sign off and let Orcanos revise, control, and distribute to relevant stakeholders for training and acknowledgment. And all is in only one place, monitoring and preventing human errors.
Let yourself be an engineer and not a writer. Generate ready-for-submission documents easily from your database.
We trace slightly differently. It is not just a matter of artifacts but also the interconnectivity of cross-organizational processes.
We bring simple and powerful traceability matrix management between any ALM and QMS artifacts. It connects all parties in a single workflow process, linking any artifact into one workplace, whether it is R&D or quality one.
Trace the interconnections of cross-organizational processes, allow automation as data cascading between processes, and make the whole greater than the parts.
Be an engineer, not a writer, and make sure the only challenges you face are within your field of expertise.Rather than dealing with bureaucracy, concentrate on development and eliminate back and forth in development. Get Orcanos to produce your paperwork in a compliance-ready format.
Trace the interconnections of cross-organizational processes, allow automation as data cascading between processes, and make the whole greater than the parts.
Save time and efforts by allowing simple tracking to know what is happening within the product lifecycle and provide an impact analysis of any defined changes.
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