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Top 10 questions you need to ask any eQMS vendor for ensuring Regulatory Compliance: ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11



📢 Introducing Orcanos: Ensuring Regulatory Compliance 🌐

Orcanos is a leading provider of innovative solutions for ensuring regulatory compliance in the medical device industry. With a strong focus on ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11, Orcanos is dedicated to helping organizations navigate the complex landscape of regulatory requirements.

🔬 Why Regulatory Compliance Matters

In the medical device industry, regulatory compliance is of utmost importance. It ensures that products are safe, effective, and meet the highest quality standards. Compliance with ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11 is not only a legal requirement but also a critical factor in building trust with customers and stakeholders.

🌟 Orcanos: Your Trusted Compliance Partner

Orcanos understands the challenges faced by medical device companies when it comes to regulatory compliance. That’s why we have developed a comprehensive suite of software solutions that streamline compliance processes, reduce risks, and enhance overall efficiency.

🔐 ISO13485 Compliance: Quality Management System

ISO13485 is an international standard that sets out the requirements for a quality management system specific to the medical device industry. Orcanos provides a robust QMS software that helps organizations establish and maintain compliance with ISO13485, ensuring that all quality processes are effectively managed and documented.

📝 FDA 21 CFR Part 820 Compliance: Quality System Regulation

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines the requirements for the design, production, and distribution of medical devices in the United States. Orcanos offers a comprehensive solution that enables companies to meet these requirements, ensuring that their products are safe and effective.

🔒 21 CFR Part 11 Compliance: Electronic Records and Signatures

21 CFR Part 11 focuses on the use of electronic records and signatures in the medical device industry. Orcanos provides a secure and compliant electronic document management system that allows organizations to manage, store, and retrieve electronic records while maintaining data integrity and security.

🚀 Take Your Compliance Efforts to the Next Level

With Orcanos, you can take your regulatory compliance efforts to the next level. Our user-friendly software solutions empower organizations to streamline their compliance processes, reduce costs, and improve overall product quality.

01. Ensuring Regulatory Compliance: ISO13485, FDA 21 CFR Part 820, and 21 CFR Part 11

Orcanos is a company that specializes in providing medical device software solutions. They have taken significant steps to ensure compliance with important regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and 21 CFR Part 11. Orcanos achieves compliance with ISO 13485 by implementing a robust quality management system that covers all relevant aspects of medical device development, manufacturing, and distribution. This includes processes for design controls, risk management, document control, supplier management, and more. For FDA 21 CFR Part 820 compliance, Orcanos aligns its processes with the Quality System Regulation and includes comprehensive controls and procedures required by the regulation. This includes management responsibility, design controls, purchasing controls, and more. Orcanos also ensures compliance with FDA 21 CFR Part 11 by implementing controls and procedures within its software solutions for electronic record keeping and electronic signatures. This includes electronic record management, system validation, audit trails, access controls, and electronic signature functionality. Orcanos’ software solutions enable customers to maintain accurate and reliable electronic records while ensuring the integrity and authenticity of the data.

02. Efficient and Compliant: Pre-Validated System and Templates for Base Settings

Orcanos is a quality management software that aligns with the U.S. FDA’s regulations on electronic records and signatures. It offers features such as storing data in an easily accessible format, implementing secure electronic signatures, providing audit trails, enforcing security measures, and conducting operational system checks. Orcanos also offers training for individuals using electronic record systems. Additionally, Orcanos provides pre-set templates and processes to validate base settings, ensuring compliance with FDA regulations. These templates include predefined test scripts to help organizations meet their specific needs and maintain regulatory compliance.

03. How Supplier Operational in MD and/or Pharma Market Can Support Small and Medium Businesses

Orcanos is an advanced quality management system designed to serve businesses in various industries, including the Medical Device and Pharmaceutical sectors. It offers comprehensive solutions for product lifecycle management, quality management, risk management, and compliance with industry standards and regulations. Orcanos is tailored to meet the specific needs of small to medium-sized businesses, offering scalable solutions that are both powerful and user-friendly. The system is affordable and cost-effective, helping SMBs avoid the high costs of non-compliance and poor quality management. Orcanos provides robust customer support and training services, ensuring that all users can fully utilize its features. It also offers integration with existing systems and flexibility in deployment options. Overall, Orcanos is a valuable tool for SMBs in the MD and Pharma industries, helping them streamline workflows, improve product quality, and maintain regulatory compliance.

04. Efficiently Implementing the Document Management System Module in Less Than 3 Months

Orcanos is a user-friendly and easy-to-implement Document Management System (DMS) that offers several features to expedite the setup process. As a cloud-based solution, Orcanos can be quickly deployed without complex hardware installation or software configuration. The intuitive user interface reduces the time needed for users to familiarize themselves with the system. Orcanos also provides comprehensive training resources and onboarding assistance to ensure efficient usage of the DMS module. The system offers predefined templates and workflows for document creation, approval, and management, which can be customized to suit the organization’s unique needs. Data migration tools help organizations transfer existing documents and data into the new system. Automated document control tasks, such as routing, review, approval, and archiving, are handled by the system, further reducing implementation time. The Orcanos DMS is scalable, allowing businesses to start small and expand as needed. By incorporating these features, Orcanos enables organizations to transition to their system in less than three months, depending on their specific requirements and resources.

05. Ensuring Seamless Document Migration: Batch Exporting in Exchangeable Formats

Orcanos’ quality management system offers a range of features that make data exportation easy and efficient. Users can export their data in various formats, including Microsoft Office files and PDFs. The batch export feature allows for the export of multiple documents at once, saving time and effort. Orcanos also maintains the file structure and metadata during the export process, preserving important information and making it easier to import into a new system. The system can also export log files to ensure historical data and audit trails are not lost. With an intuitive interface and compliance with regulations, Orcanos makes it simple to navigate and select files for export. Additionally, technical support is available to assist with complex data migrations, ensuring a smooth transition.

06. Setting Access Restrictions: Group and Role/User-Based

Orcanos’ Quality Management System (QMS) offers robust user access controls to ensure the security and integrity of the system. With features like user roles, user groups, granular permissions, Access Control List (ACL), audit trails, and data security, Orcanos provides a comprehensive solution for managing user access.

User roles allow administrators to assign predefined permissions to individual users based on their job function. This ensures that each user has the appropriate level of access to perform their tasks. User groups are useful for larger organizations where multiple users have similar functions and require the same level of access.

Granular permissions enable administrators to specify what actions a role or group can perform on specific documents. This level of control allows for fine-tuning of access permissions, ensuring that users only have access to the necessary information.

The Access Control List (ACL) feature allows administrators to set permissions for each individual document, determining which roles or groups can access it and what actions they can perform. This provides a high level of control and security over sensitive information.

Audit trails track and log all user actions within the system, creating a record of any changes to access permissions. This promotes accountability and aids in compliance with regulations and standards.

By offering granular control over user access, Orcanos ensures the security and confidentiality of data within the system. This is particularly important for organizations handling sensitive information.

Overall, Orcanos’ QMS provides a robust and comprehensive solution for managing user access, ensuring the security and integrity of the system.

07. Efficiently Manage Document Sign Off with Set Roles

Orcanos’ Quality Management System (QMS) offers robust document control features, including role-based sign-off permissions. This means that only users with specific roles can approve certain documents, ensuring the appropriate individuals or groups are involved in the review and approval process. Orcanos also allows administrators to set default sign-off permissions for each document or group of documents, automating the process and ensuring consistency. The system includes workflow management capabilities, allowing documents to be guided through the review and approval process with sign-off stages assigned to specific roles. Notifications can be automatically sent to users when a document is ready for sign-off, ensuring timely completion. Orcanos maintains a detailed audit trail for each document, providing transparency and aiding in regulatory compliance. Additionally, the system supports electronic signatures for document sign-off, providing an extra level of security and accountability.

08. Filtering Documents by Publication Date: Identifying Unchanged Documents for 1-3 Years

Orcanos’ Quality Management System (QMS) offers a powerful filtering system that allows users to sort and filter documents based on various criteria, including publication date. This feature is beneficial for keeping track of document updates and ensuring regulatory compliance. Users can utilize advanced search and filtering capabilities to locate documents based on metadata, such as publication date. Custom filters can also be created to show only documents that haven’t been updated for a specific period. Saved searches make it easy to regularly check on documents that haven’t been updated. Automated notifications can be set up to alert users when a document hasn’t been updated within a specific timeframe. The system’s reporting and dashboard capabilities provide visual representations of document statuses based on applied filters, helping to identify documents that may need review or updating. Audit trails track every action performed on a document, including publication and modification dates, allowing for precise filtering and ensuring an accurate document history. By utilizing these features, users can efficiently filter and track documents based on their publication date, ensuring that no documents go without review or updates for extended periods.

09. Rapid Response: Get the Support You Need Within 24 Hours!

Orcanos prioritizes prompt and efficient customer support to address any system issues users may encounter. They offer multiple communication channels, such as email, phone, and live chat, to provide convenient assistance. Orcanos utilizes a ticketing system to track and manage user issues, ensuring timely resolution. They also maintain a knowledge base and FAQ section on their website, allowing users to find immediate solutions to common problems. For critical issues, Orcanos has an emergency response team trained to quickly resolve urgent problems. Additionally, they assign dedicated Customer Success Managers to clients, who are familiar with their specific needs and setups. Orcanos provides training resources and comprehensive documentation to help users understand the system better and resolve issues independently.

10. Setting Up Your System: Exploring the Support Available

Implementing a new Quality Management System (QMS) can be a complex process, but Orcanos offers robust support to assist customers during the setup and definition phase. They provide initial setup and configuration assistance, assigning dedicated Customer Success Managers to clients to ensure their specific requirements are met. Orcanos also offers comprehensive onboarding and training resources, data migration support, integration support with other systems, template setup, customization support, and regulatory compliance guidance. With this extensive setup support, Orcanos helps customers effectively define their QMS to meet their needs and regulatory requirements.

11. The Importance of System Validation Post-Installation and Updates

Orcanos is dedicated to helping its customers throughout the system lifecycle, including during the crucial system validation process. System validation is essential to ensure that the software is installed correctly, functions properly, and meets regulatory requirements. Orcanos provides various forms of support for system validation, including guidance and assistance, predefined validation templates, training resources, support for automated testing, documentation assistance, support for change control processes, and dedicated Customer Success Managers. By offering these support mechanisms, Orcanos ensures that users can effectively validate their Quality Management Systems (QMS) after installation and updates.

12. Enhancing Workflow Efficiency with Custom Processes: Training, CAPA, Complaints, Change Control, Action List, and More

Orcanos’ Quality Management System (QMS) offers flexibility and customization for organizations to tailor their processes such as Training, CAPA, Complaints handling, Change Control, and Action Lists. With customizable workflows, custom fields and forms, integrated processes, document management, action lists, task management, training management, audit trails, and reports and dashboards, Orcanos enables efficient and effective process management. This comprehensive system ensures regulatory compliance and provides valuable insights for decision making.

If you’re interested in learning more about how Orcanos can help be tailored to your organization, click here.

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