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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Carizma QM is an online application designed to assist users in overseeing the complete lifecycle of regulated documents, encompassing stages from drafting and reviewing to approving, releasing, and archiving. It enables the creation and management of essential documents, such as Standard Operating Procedures (SOPs), through integrated workflows that facilitate the review and approval process. Upon approval, the system automatically initiates a training workflow where users must acknowledge they have read and understood the document. The software incorporates an electronic signature feature that complies with 21 CFR Part 11 regulations, ensuring a display of users who have acknowledged their understanding of the documents. Additionally, it maintains a validated audit trail, enhancing users' ability to manage regulated documents directly within Carizma QM. Authors can specify crucial information, including the document type (such as SOP, work instruction, form, or checklist), the document title, the process owner (the relevant department), and the user groups to which the document applies, along with setting a review cycle. Users are notified via email in a timely manner when a document requires their review, and Carizma QM generates the initial document framework to streamline this process. Overall, the software simplifies and enhances the management of regulated documentation through its comprehensive features.

Description

Ensure timely and budget-friendly delivery of products with Orcanos, a comprehensive software solution for Application Lifecycle Management (ALM) and Quality Management Systems (QMS). This cost-effective cloud-based platform encompasses various functionalities, including Requirements Management, Test Management, Document Control, Risk Management, and Quality Management, all centralized in one repository. Moreover, Orcanos offers intuitive dashboards and real-time alerts, enabling organizations to monitor their projects effectively and maintain visibility on progress as it occurs. The Orcanos e-DMS functions as a complete document management system tailored for users to create, track, search, archive, and approve all documentation pertinent to each phase of launching a medical device. By facilitating quick access to documents related to planning, design, development, manufacturing, and servicing, the e-DMS enhances the efficiency of quality processes while significantly shortening the time to market. Additionally, this streamlined approach allows businesses to focus on innovation and meeting regulatory requirements without sacrificing productivity.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Adobe Acrobat
Jira
Microsoft 365
Microsoft Word
Salesforce

Integrations

Adobe Acrobat
Jira
Microsoft 365
Microsoft Word
Salesforce

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$69.00/month/user
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Axicos

Founded

2007

Country

Switzerland

Website

www.axicos.com/software-solutions

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com/compliance/qpack-medical-compliance/

Product Features

Legal Document Management

Access Controls
Archiving & Retention
Collaboration
Contract Management
Document Assembly
Document Indexing
Document Tagging
Full Text Search
Version Control

Product 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

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