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Vertical-Specific

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### Document Management and Control
Users consistently highlight Orcanos's document management and control functionalities as efficient and user-friendly, particularly praising features like document tracking, version control, and document approval processes. While some users mention minor drawbacks such as slow upload speeds and interface issues, overall, Orcanos is commended for its ability to streamline document management processes and enhance document control within organizations. The platform's traceability matrix, document sharing options, and digital signature capabilities are also noted as valuable tools for ensuring compliance and accountability in document management practices.

### Requirements Management
User feedback on Orcanos's requirements management functionality is generally positive, with many users highlighting the platform's ability to effectively manage and track requirements throughout the development process. The traceability matrix feature is particularly praised for its role in ensuring clear alignment between requirements and project outcomes. However, some users have expressed concerns about the complexity of the traceability matrix, citing challenges in differentiating between mapped and unmapped requirements. Despite these minor drawbacks, Orcanos is recognized for its flexibility and customization options, allowing users to tailor the system to meet their specific requirements management needs.

### Traceability and Tracking
Users consistently praise Orcanos for its robust traceability and tracking capabilities. They appreciate the system's ability to provide a structured approach to document management, ensuring that all changes are tracked and recorded efficiently. The traceability matrix and version control features are highlighted as particularly beneficial, allowing for easy identification of document history and facilitating collaboration among team members. Despite some minor concerns about the complexity of the traceability matrix, overall, users find Orcanos to be a reliable tool for maintaining traceability and ensuring document integrity throughout the lifecycle.

### Test Management
Users generally praise Orcanos for its comprehensive test management capabilities. The tool is commended for its efficiency in managing test runs, test cases, and test protocols. Users appreciate the support provided by the Orcanos team members in navigating the testing documents and processes. However, some users have raised concerns about minor issues such as small text size in test cases and the potential for accidentally skipping steps, leading to incomplete test cases. Despite these minor drawbacks, Orcanos is recognized for its ability to streamline test management processes effectively.

### Risk Management
User feedback consistently highlights Orcanos's risk management as a standout feature, with many praising its comprehensive risk analysis tools and the ease of creating and maintaining traceability between various items. The ability to customize for personal needs and the helpfulness of the support team have also been noted as positive aspects. Additionally, Orcanos's risk management functionality has been commended for its attention to detail and the alerts it provides for risks and problems. The platform's holistic approach to integrating risk management with other processes has garnered appreciation for its ability to manage workflows effectively and ensure end-to-end consistency.

### Medical Device Lifecycle Management
Users consistently highlight Orcanos's robust medical device lifecycle management features, emphasizing its ability to streamline processes and ensure compliance with regulatory standards. The platform's integrated approach to managing the entire lifecycle of medical devices has been commended for its efficiency and effectiveness in supporting development activities. Additionally, users appreciate Orcanos for providing a centralized solution that facilitates traceability and enhances overall product quality throughout the lifecycle.

### Quality Management Systems (QMS
Users unanimously praise Orcanos for its robust quality management systems (QMS) capabilities. They appreciate how Orcanos streamlines processes, enhances compliance, and facilitates efficient document control within their organizations. The platform's ability to centralize quality procedures such as change control, CAPA, and equipment management has garnered positive feedback for its effectiveness in maintaining and improving QMS standards. Additionally, users find Orcanos instrumental in managing calibration records, ensuring timely equipment maintenance, and promoting adherence to regulatory requirements. Despite occasional challenges with clarity and functionality, users value Orcanos as a valuable tool for electronic QMS management, especially in today's dynamic business landscape.

### Compliance and Audits
User sentiment regarding Orcanos's compliance and audits capabilities is highly positive. Reviewers consistently praise Orcanos for its ability to streamline compliance audits, track document inspections, and ensure regulatory requirements are met. Users appreciate the platform's intuitive interface, ease of use, and efficient tracking of tasks and artifacts. Orcanos is commended for its role in facilitating compliance with medical device standards and regulations, making it a valuable tool for companies aiming to achieve and maintain regulatory compliance.

### Regulatory Requirements and Standards
Users consistently highlight Orcanos' strong adherence to regulatory requirements and standards, particularly in the medical device industry. The platform's ability to ensure full compliance with 62304 and 13485 standards is widely appreciated, providing users with confidence in meeting regulatory obligations. Despite some concerns about specific functionalities and certification gaps, Orcanos is generally recognized for its effectiveness in supporting regulatory compliance and maintaining quality standards in document control and regulatory submissions.

### Project and Workflow Management
Users consistently highlight Orcanos's project and workflow management as a key strength of the platform. They appreciate the flexibility and customization options available for organizing multiple projects and teams efficiently. While there may be a learning curve initially, users find that once familiar with the system, managing projects becomes intuitive. The ability to trace projects as a cohesive unit and the ease of managing different versions within a single platform are also commended. Despite some minor challenges in navigation and data response times, users generally find that Orcanos excels in providing a reliable and configurable solution for project and workflow management.

### Change and Release Management
User sentiment regarding Orcanos's change and release management features is mixed. While some users appreciate the system's ability to track changes and manage releases efficiently, others find certain aspects challenging, such as writing comments or navigating between system parts. The platform's ease of use and customization options are highlighted as strengths, but concerns about the interface being too simple and the system's speed and bugs in each release are also raised. Despite these mixed opinions, Orcanos seems to offer valuable tools for change and release management, aiding in compliance and workflow consistency for its users.

### Customization and Configuration
Users consistently praise Orcanos for its robust customization and configuration capabilities. The system's flexibility and adaptability allow for tailored solutions to meet specific user needs, enhancing workflow efficiency. While some users note that the effectiveness of customization may depend on the skill of the implementer, overall, Orcanos is lauded for its ability to empower organizations to create custom processes and forms, ultimately streamlining operations. The high level of configurability and the ease of creating custom process flows with varying levels of approval are highlighted as key strengths by users. Additionally, the system's traceability options are commended for being configurable and tailored to project requirements, simplifying V&V processes. Users appreciate the system's adaptability, scalability, and the comprehensive solutions it offers, such as design traceability and eForms. The ability to gradually implement multiple modules based on company needs is seen as a valuable feature, allowing for controlled growth and customization. Despite some initial challenges in navigating the admin module, users find Orcanos to be a highly configurable system with excellent support available when needed.

### User Interface and Experience
User sentiments vary widely regarding Orcanos's user interface and navigational ease. While some users find the adaptability and organization of the dashboard easy to navigate, others express frustration with the system's slow performance and lack of intuitiveness. The learning curve to understand and customize workflows is highlighted as a challenge, with some users noting that the interface feels outdated and cumbersome. Despite mixed opinions, Orcanos seems to offer a range of customization options and support resources to help users overcome initial hurdles and maximize the platform's capabilities.

### Training and Support
User sentiment regarding Orcanos's training and support capabilities appears to be varied. While some users appreciate the helpful and knowledgeable support team, others express concerns about the complexity and cost associated with training. The platform's ability to provide training templates and assistance in setting up modules is acknowledged positively by some, but there are also mentions of difficulties in adding users and setting up training. It seems that the effectiveness of Orcanos's training and support may depend on individual user experiences and needs.

Users have made several recommendations based on their experiences with Orcanos. Firstly, they suggest thoroughly checking if Orcanos meets all expectations and challenging the system with test cases that reflect expected processes. Additionally, users recommend improving the onboarding process to make it more efficient. They also mention difficulties with the chat functionality and ticket raising process, recommending enhancements in these areas for better user experience. Furthermore, users note the absence of ISO 13485 certification, which poses a challenge for medical device companies considering Orcanos as a critical supplier.

Easy-to-use software: Users have consistently praised Orcanos for its ease of use, with many stating that it has a convenient interface and is simple to navigate. Some users have mentioned that the drag-and-drop feature for uploading documents is particularly helpful. 

Useful functions: Many reviewers have noted that Orcanos offers a variety of useful functions, including document sharing, signing, tracking, and collaboration. This feature helps increase productivity and efficiency in managing quality system processes.

Flexibility: Reviewers appreciate Orcanos' flexibility in allowing customization options for process flows and forms within the system. This makes change management an easy task while providing highly configurable interfaces that enable controlled progress tracking through product development efforts.

Slow Response Time: Orcanos' technical service has received negative feedback from reviewers due to its slow response time. Some users have reported waiting between two and three days for a response after opening a call in the system, which they consider to be too slow.

Complex Platform: The complexity of Orcanos' platform is a major source of frustration for some users. Reviewers note that the system requires training to be used correctly, and all training comes at an extra cost. Additionally, Orcanos can be difficult to navigate, particularly on the backend, making it challenging to customize workflows effectively.

Poor User Interface: Many users find Orcanos' user interface (UI) to be subpar. According to reviews, the UI is not straightforward or intuitive, requiring guidance and less intuitive than other software tools. Furthermore, there are several annoying aspects of UI that need improvement such as lack of flexibility in creating word documents and more tools for batch editing items.

Oranos is the eponymous ALM / Quality Management solution from the company in Tel Aviv, with ALM components that enable users to plan, approve, trace and validate industry requirements, manage audits and ensure regulatory compliance, all within an integration into a Microsoft Office environment. Its Quality Management System allows users to adhere to strict MDR/FDA regulations and ISO quality standards by eliminating paper-based QMS processes.

Design Control (ALM)

Quality Management (QMS)

Premium (ALM & QMS)

monday dev is a product to plan, track, and ship software while staying connected to the business, featuring AI capabilities that allow it to analyze bugs as they are submitted, summarize product documents, and automatically assign tasks.

Basic

Standard

GitLab is an intelligent orchestration platform for DevSecOps, where software teams enable AI at every stage of the software lifecycle to ship faster. The platform enables teams to automate repetitive tasks across planning, building, securing, testing, deploying, and maintaining software.

GitLab Premium

GitLab Ultimate

GitLab Premium (self-managed)

GitLab Ultimate (self-managed)

GitLab Free (self-managed)

GitLab Free

GitLab

Orcanos

Application Lifecycle Management (ALM) is closely related to Agile Development but is broader in scope. Where agile development is primarily a way of organizing development cycles within the product development process, ALM is broader in scope and is concerned with development, but also delivery and maintenance of the software over the life of the application. ALM covers a product from inception to retirement, not just the development component of a product’s life.

Application Lifecycle Management (ALM)

Orcanos Software

Orcanos Compliance Management for Medical Device Cloud Solution

ALM AND QMS
Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records

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Orcanos

Overview

What is Orcanos?