Orcanos ALM and Quality Management System (QMS) First Time Tutorial

This video provides an introductory tutorial to Orcanos ALM (Application Lifecycle Management) and QMS (Quality Management System), demonstrating its core functionalities for managing projects, requirements, testing, risk, and documents within a regulated environment. The speaker guides users through the initial setup and navigates the system's various modules, emphasizing how Orcanos facilitates compliance and operational efficiency by centralizing critical development and quality processes.

The tutorial begins with a simple onboarding process, allowing users to select a project type and name, after which the system automatically creates the project structure. It then introduces the "product tree," a hierarchical representation of project documents and electronic records, such as market, system, software, hardware, and mechanical requirements. The video provides an overview of the system's interface, including a user area for personalization, a modules menu to switch between views (product tree, dashboard, work items, document control, service center, admin), a project selector, and a search panel. Dashboards are highlighted as customizable areas for reports and quick access to tutorials, demonstrating the system's flexibility in presenting relevant information.

A significant portion of the tutorial focuses on managing electronic records and ensuring traceability. It illustrates how to navigate the product tree to view specific documents, such as a software requirement document, which contains headings and actual requirements, each assigned a unique identifier. The process of adding new work items, like a software requirement, is demonstrated, emphasizing that Orcanos uses "work items" as a versatile concept for managing various electronic forms, including defects, test cases, and CAPAs. The video also showcases the "tracing mode," a dual-pane interface that allows users to easily link low-level items (e.g., test cases) to high-level items (e.g., software requirements), establishing critical traceability for validation and compliance.

Finally, the tutorial delves into document control and administrative features. The document control module offers a hierarchical view of workspaces, folders, and DMS (Document Management System) items, enabling users to upload and manage documents with version control (revisions). Electronic signatures are mentioned as a key feature for tracking progress and defining routing processes. The administration section is presented as a comprehensive control panel for customizing nearly every aspect of the system, including user and group management, project configuration, electronic form customization, custom fields, traceability rules, data sharing, alerts, email notifications, and add-ons like the DMS importer and DocGen for exporting data. The FMEA panel for risk management is also briefly highlighted, underscoring the system's integrated approach to quality and compliance.

Key Takeaways:

• Integrated ALM and QMS: Orcanos provides a unified platform for Application Lifecycle Management and Quality Management System, covering requirements, testing, risk, CAPA, and document control, which is crucial for regulated industries like life sciences.
• Hierarchical Product Tree for Electronic Records: The system organizes project data, including various types of requirements (market, system, software, hardware), into a hierarchical "product tree," representing electronic records that can be generated into formal documents.
• Robust Requirements Management: Users can easily add and manage requirements, each assigned a unique identifier and prefix, facilitating clear tracking and management throughout the product lifecycle.
• Critical Traceability Functionality: Orcanos features a "tracing mode" that enables linking low-level items (e.g., test cases) to high-level items (e.g., requirements), which is essential for demonstrating compliance and validation in regulated environments.
• Comprehensive Document Control (DMS): The system includes an electronic Document Management System for organizing, uploading, and managing documents with revision control, supporting GxP and 21 CFR Part 11 requirements.
• Electronic Signatures for Compliance: Electronic signature capabilities are integrated, allowing for tracking progress and defining routing processes, which is vital for audit trails and regulatory adherence.
• Flexible "Work Items" Concept: Orcanos utilizes "work items" as a versatile framework for managing various electronic forms, including requirements, defects, test cases, and CAPAs, enabling standardized data capture.
• Extensive Customization Options: The administration panel allows for deep customization of electronic forms, custom fields, traceability rules, user roles, and permissions, adapting the system to specific organizational needs and regulatory frameworks.
• Integrated Risk Management (FMEA): A dedicated FMEA panel signifies the system's built-in capabilities for risk management, a cornerstone of quality systems in medical device and pharmaceutical development.
• Collaborative Features: The system supports simultaneous work on documents, data sharing settings, and configurable alerts and email notifications based on events, fostering team collaboration and oversight.
• Add-ons for Data Integration: Orcanos offers add-ons like a DMS importer for migrating existing QMS data and a DocGen tool for exporting data into standard formats (MS Word, PDF), enhancing data portability and integration.
• Project-Specific User Roles: Users can be assigned different roles and permissions across multiple projects, allowing for granular control over access and responsibilities (e.g., a user can be a developer in Project A and a tester in Project B).

Tools/Resources Mentioned:

• Orcanos ALM (Application Lifecycle Management)
• Orcanos QMS (Quality Management System)
• Orcanos DMS Importer (add-on for importing existing QMS documents)
• Orcanos DocGen (add-on for exporting data to MS Word or PDF)

Key Concepts:

• ALM (Application Lifecycle Management): A comprehensive approach to managing the life cycle of an application, from conception to retirement.
• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Requirements Management: The process of documenting, analyzing, tracing, prioritizing, and agreeing on requirements and then controlling change and communicating to relevant stakeholders.
• Test Management: The process of managing tests, including planning, designing, executing, and reporting on test activities.
• FMEA (Failure Mode and Effects Analysis): A systematic, proactive method for evaluating a process, product, or service to identify where and how it might fail and to assess the potential impact of different failures.
• CAPA (Corrective and Preventive Actions): Processes for identifying, documenting, and eliminating the causes of nonconformities and preventing their recurrence.
• Document Control: The process of managing documents throughout their lifecycle, including creation, review, approval, distribution, and archiving, ensuring their accuracy and availability.
• Electronic Signature: A digital equivalent of a handwritten signature, used to authenticate the identity of the signer and the integrity of the signed data, often critical for regulatory compliance (e.g., 21 CFR Part 11).
• Traceability: The ability to track the relationship between different items (e.g., requirements to test cases, or design specifications to verification activities), crucial for validation and auditability.
• Work Items: A generic term used in Orcanos to represent any managed electronic form or record within the system, such as requirements, defects, test cases, or CAPAs.
• Product Tree: A hierarchical visual representation of all project-related documents and electronic records within the Orcanos system.
• DMS (Document Management System): A system used to store, manage, and track electronic documents and electronic images of paper-based information.

Examples/Case Studies:

• Project Onboarding: Demonstrates creating a new project by selecting a project type and setting a name.
• Hierarchical Document Structure: Illustrates the "product tree" with examples like "market requirements spec," "system requirements spec," "software requirements," "hardware requirements," and "mechanical requirements," showing how documents and headings are structured.
• Adding a Software Requirement: Shows the process of creating a new "software requirement" work item, giving it a name and description, and noting its unique identifier.
• Creating Traceability: Demonstrates linking a "test case" (low-level item) to a newly created "software requirement" (high-level item) using the tracing mode and defining a "test coverage" link type.
• Document Upload and Revision: Illustrates adding a "software test result document" to a folder within document control by dragging and dropping a file, noting that each change increases the document's revision number.