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Average Ratings 0 Ratings
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
Virje meets the standards set forth by 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you're feeling daunted by the complexities of Part 11 software validation, rest assured that help is just a click away, no matter where you are or when you need it. By eliminating paperwork, cutting costs, and enhancing productivity through automation and unified collaboration, it becomes an ideal solution for small to medium-sized enterprises. Designed specifically for medical device quality management, this system is constructed to be adaptable to your unique workflows and processes, ensuring you don’t have to make any sacrifices. It features configurable change order approvals that can be tailored by employee role and document type, along with timely notifications sent to accountable team members throughout every phase of the change process. Users can assign material dispositions for specific documents, gain easy access to both released and archived versions, and quickly view the history of document changes. Additionally, it tracks where-used locations and the distribution of hard copies, while also providing reminders for periodic document reviews to ensure compliance and efficiency remain top priorities. This comprehensive approach not only streamlines quality management but also empowers organizations to maintain rigorous standards effortlessly.
API Access
Has API
API Access
Has API
Integrations
Adobe Acrobat
Microsoft Word
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
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
Virje
Country
United States
Website
www.virje.com
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
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management