With increasing risk of loss due to theft, computer malfunction or natural disaster cybersecurity and Information Security activities are implemented at a high level to protect data, information, systems, and users. Orcanos Software is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specialises in the medical device industry.

Orcanos leads in providing requirements verification traceability matrix. Orcanos Design Input (DI) and Design Output (DO) for requirements management tool simplify tracking of your requirements. These are flexible enough to serve SMBs and powerful for enterprises. Key features include:
• Single repository for all types of requirements management (DI/DO)
• Simple Import/Export from Word
• Collaboration
• Medical Device compliance, with 21 CFR Part 11 support
• End-to-end traceability with impact analysis
• Real-time dashboards, alerts, and notifications

Requirements and threats are documented in much the same way as to ensure traceability and repeatability. Proactive management is offered by Orcanos to implement, execute, control, test, verify, and validate that the requirements have been met and the applicable threats have been mitigated. The management difference is while requirements must ultimately be met, threats are managed and mitigated on the likelihood and severity of the threat to the users, businesses, and systems. Risks are documented to show management and mitigation. Documenting these requirements and threats and their supporting details is the key to the proactive and repeatable effort that is needed. The team believes the best approach in doing this is to keep this management as straightforward as possible and as detailed as needed to plan, execute, and control the program or business.

As Software Company Orcanos can reduce rework through effective requirements management. It is essential to have clear understanding of requirements so that it can give a clear and accurate vision to the development team to pursue their activities. As part of the Orcanos ALM – requirements management tools, the Orcanos traceability tool is simple and powerful for traceability matrix management between any ALM or QMS artifact, such as requirements, test cases, FMEA risk items, customer complaints, CAPA and more.

Orcanos has many years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, assisting them in building their operational excellence. The Orcanos solution is a perfect match for SMBs as well as for enterprises.

About Orcanos:

ALM and Quality Management

Orcanos Software was founded in 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specialises in the medical device industry. For more information about please, visit https://www.orcanos.com/compliance/

Contact
8 Tozeret Ha'aretz Street
Tel Aviv, Israel
+972-3-5372561
[email protected]