Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Paper-based documentation can lead to increased space requirements, heightened risks, and excessive effort! It is frequently a trigger for 483s during FDA inspections. To address these challenges, an automated document control system is essential for businesses. Designed specifically for highly regulated sectors, Docs-IQ serves as a web-based document management platform. Transitioning to the Docs-IQ system enables companies to adhere to their standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and various other regulatory standards. The pharmaceutical sector encounters a vast array of documents daily, and without a robust system, it risks becoming overwhelmed by paper. Implementing a streamlined document management system has become critical in today’s environment. A document typically passes through nine distinct stages before it is either archived or destroyed. Effectively managing the entire lifecycle of a document, from creation to storage and eventual disposal, poses significant challenges in a manual, paper-centric organization. Each phase of this lifecycle demands substantial paperwork, along with considerable time, effort, and resources, underscoring the need for a more efficient approach to document management. As such, optimizing these processes can not only enhance compliance but also improve overall productivity.
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
No
API Access
Has API
No
Integrations
EPIQ QMS by Caliber
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
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
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/document-management-system/
Vendor Details
Company Name
Virje
Country
United States
Website
www.virje.com
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
No
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No