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Average Ratings 1 Rating
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
Efficiently collect, create, approve, and oversee requirements for intricate systems throughout the complete project lifecycle. Ensure seamless synchronization and effortless access to all Polarion data through a fully browser-based platform. Foster immediate communication among analysts, engineers, QA personnel, and DevOps teams through threaded discussions, wikis, notifications, alerts, and more. Successfully navigate audits, compliance checks, or regulatory inspections with traceability that is straightforward to implement and assured through automatic change control of each requirement. Oversee work items and documents through workflows that dictate how and when they transition from one state to another based on customizable rules, complete with comprehensive audit trails, electronic signatures, and security measures. A unique feature, Polarion LiveDocs, allows for concurrent and secure collaboration on specification documents, ensuring that every paragraph is distinctly identifiable and traceable, thereby enhancing team productivity and accountability. This approach not only streamlines processes but also elevates the quality and reliability of project outcomes.
API Access
Has API
No
API Access
Has API
No
Integrations
Adobe Acrobat
Yes
LDRA Tool Suite
No
Microsoft Word
Yes
QVscribe
No
SureView
No
VectorCAST
No
Integrations
Adobe Acrobat
No
LDRA Tool Suite
Yes
Microsoft Word
No
QVscribe
Yes
SureView
Yes
VectorCAST
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Axicos
Founded
2007
Country
Switzerland
Website
www.axicos.com/software-solutions
Vendor Details
Company Name
Siemens
Founded
1847
Country
Germany
Website
polarion.plm.automation.siemens.com/products/polarion-requirements
Product Features
Legal Document Management
Access Controls
No
Archiving & Retention
No
Collaboration
No
Contract Management
No
Document Assembly
No
Document Indexing
No
Document Tagging
No
Full Text Search
No
Version Control
No
Product Features
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
No
History Tracking
No
Prioritization
No
Reporting
Yes
Status Reporting
No
Status Tracking
Yes
Summary Reports
No
Task Management
Yes
To-Do List
No
Traceability
No
User Defined Attributes
No
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No