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Ratings and Reviews 0 Ratings
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What is Orcanos ALM and QMS?
Orcanos provides a robust software solution designed for Application Lifecycle Management (ALM) and Quality Management Systems (QMS), ensuring that products are delivered on time and within budget. This efficient cloud-based platform integrates functionalities such as Requirements Management, Test Management, Document Control, Risk Management, and Quality Management into a single repository. Users benefit from intuitive dashboards and real-time alerts that enhance project monitoring and visibility throughout the development process. The Orcanos e-DMS serves as a comprehensive document management system, enabling users to create, track, search, archive, and approve documentation critical to each stage of medical device launch. By streamlining access to essential documents related to planning, design, development, manufacturing, and servicing, the e-DMS improves the efficiency of quality processes and significantly reduces time to market. Furthermore, this optimized workflow empowers organizations to prioritize innovation and adhere to regulatory standards while maintaining high levels of productivity, ultimately fostering a culture of continuous improvement.
What is MyCellHub?
Optimize the various processes related to batch records, sanitation, environmental monitoring, and inventory management. Leverage software designed specifically for Good Manufacturing Practice (GMP) to improve the production of advanced therapies. This solution acts as a cohesive platform to align your team towards achieving manufacturing excellence on the first attempt. Remove the disarray caused by fragmented documentation by employing a singular software system that streamlines data gathering, review, approval workflows, detailed reporting, and valuable analytics. Ensure your staff follows the appropriate protocols in a timely manner with interactive work instructions that guide them through every stage. Rest assured that this software adheres to 21 CFR part 11 and EU Vol 4 annex 11 regulations. Ease the process of information recording with features such as barcode scanning, embedded data integrity safeguards, and automated calculations. The system also possesses features for detecting out-of-spec conditions and ensuring comprehensive review and approval processes. Keep track of your samples during the testing phases seamlessly, while efficiently arranging sample plans and automating trend analysis. Furthermore, oversee tasks related to maintaining cleanroom protocols and track various production stages to guarantee optimal outcomes. This holistic strategy not only boosts operational efficiency but also cultivates a culture of responsibility and accuracy within the manufacturing environment, ultimately leading to better product quality and compliance.
Integrations Supported
Jira
Microsoft 365
Salesforce
API Availability
Has API
API Availability
Has API
Pricing Information
$69.00/month/user
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Orcanos
Date Founded
2004
Company Location
Israel
Company Website
www.orcanos.com/compliance/qpack-medical-compliance/
Company Facts
Organization Name
MyCellHub
Date Founded
2019
Company Location
Belgium
Company Website
www.mycellhub.com
Categories and Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Categories and Features
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability