Orcanos

What is Orcanos Software?

Overview

Orcanos is a cloud-based software that continuously audits medical devices, pharmaceuticals,  and other high-tech products/assets. With the Orcanos software, businesses can easily create and maintain documents related to their products or services to meet industry standards.

It offers a comprehensive suite of tools for application lifecycle management (ALM), quality management, regulatory compliance, risk management, and manufacturing execution quality control system (MES).

What is Orcanos Project Management Software Best for?

Orcanos' unique offering is that it combines design control, quality management, and regulatory compliance. Additionally, the software is popular for adaptive compliance. With this feature, Orcanos replaces the paper-based

Quality Management System (QMS) with customizable electronic forms to improve productivity and efficiency.

Orcanos Project Management Pricing

There are three comprehensive Orcanos pricing plans available. These include: 

• Design Control (ALM)
• Quality Management (QMS)
• Premium (ALM + QMS)

Also, all plans include free onboarding. While Orcanos has not published each plan's prices, it reveals that it is a 'pay-as-you-go' service. Customers can pay monthly or yearly for the pricing tier they subscribe to.

Please see the pricing breakdown table at the end or click ‘Get Pricing’ for more details. 

Orcanos Compliance Software Integrations

Orcanos can integrate with Zapier, which allows connecting two applications or web services without any coding. Through this integration, users can bring the full power of Orcanos to over 2,000 applications valuable for a business. 
A few other notable names include: 

• Jira
• Salesforce
• Slack
• GitHub
• Google Sheets

How Does Orcanos Work?

Here are the steps to set up and start using the Orcanos platform:

• Sign up for an account on the Orcanos website. Depending on your needs, you can choose a free trial or paid plan.
• Connect your existing applications, such as Microsoft Office and Google Drive, using the Zapier integration.
• Select a template that best fits your organization’s needs or create a new one from scratch.
• Create documents related to the products or services you offer, making sure to adhere to industry standards.
• Set up version control for documents, audit trails, and risk management tracking within Orcanos’s user-friendly interface.
• Use automation tools such as task assignment and notification triggers for automating document workflow processes.
• Access the reports and data analytics to keep track of performance and make informed decisions about your business’s document management processes.

We highly recommend scheduling an Orcanos demo to understand how the software works. Click "Watch Demo" above to access it for free. 

Who is Orcanos?

Due to its flexibility and adaptability, Orcanos can help organizations of all sizes. It combines design control, quality management, and regulatory compliance into one SaaS platform. Thus, making it ideal for various organizations seeking to streamline its processes.
Orcanos is feasible for: 

• Medical device manufacturers
• High-tech companies
• Pharmaceuticals

The pricing plans are also tailored to fit the needs of different organizations. Overall, Orcanos is an excellent choice for any organization looking for a comprehensive solution to manage both quality management and regulatory compliance on a single platform.

Orcanos Compliance Software Features

Requirements Management Tool

Designed to help organizations keep track of their data points for compliance and risk management. This feature allows users to define product and service requirements hierarchically. Users can also capture traceability links between their data points, and customize requirements properties.

Integrated Risk Management

It helps companies manage and prevent risk. Orcanos provides a comprehensive risk, governance, and compliance platform, allowing users to identify, assess, monitor, and report on potential risks. In addition, the tool offers powerful features such as time tracking, resource management, probability analysis, and risk data quality assessment.
Additionally, Orcanos' risk management tool enables users to create a Risk Register and conduct SWOT Analysis to gain insights into the current state of their organization's risks.

Defect Tracking

With ALM list views and dashboards, users can easily monitor the progress of their projects and identify any issues that need to be addressed. In addition, the 'Defect Tracking' application provides detailed reports and graphs of incidents, enabling users to assess any issue's impact on their project quickly.

Document Control

Manage your documents from creation to revision control, approval or sign-off, and distribution. With Orcanos' document control tool, you can easily store, manage, and track revisions of documents along with electronic signatures. 
The software also provides traceability to manage references and links between documents. Document control also enables watermarking obsolete documents to ensure users do not use outdated versions. 
The document control system is compliant with Part 11 and ISO 13485 standards. It also offers an online document collaboration feature for easy sharing of documents.

Complaint Handling System

Orcanos' complaint handling tool is designed to help organizations efficiently manage customer complaints. It enables them to contact customers and investigate the causes of the complaints quickly.
The software provides a comprehensive platform where users can log complaints, assign tasks to relevant personnel, track progress, and review all changes related to a complaint in real-time.

CAPA Management System

Orcanos provides powerful CAPA (Corrective Action and Preventive Action) management capabilities. A comprehensive workflow promptly addresses and resolves identified issues, corrective actions, or preventative actions reported by employees, customers, and suppliers.
The workflow begins with an initial incident report. It continues through stakeholders' completion of a Root Cause Analysis, plan for corrective actions, implementation to address the incident, closure, and review/re-evaluation. 
All documentation can be tracked in one place, allowing all stakeholders to access the latest versions of documents in real-time.

Is Orcanos Right for You?

If you are looking for a cloud-based platform with compliance and automation tools, then Orcanos is the right choice. It is the only software that combines design control, quality management, and regulatory compliance in one SaaS platform. 

Orcanos ALM ensures full compliance with the regulations set out by the FDA for electronic records and electronic signatures. In addition, the platform ensures compliance according to ISO 13485, IEC 62304, 21 CFR Part 11, and

ISO 14971. The combination makes it an ideal solution for businesses in regulated industries, such as medical device manufacturers.

Notable customers of Orcanos include General Electric, ReWalk, Medtronic, Advanced Oncotherapy, and Zimmer MedizinSysteme.

Orcanos Pricing Breakdown