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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

Integrations

EPIQ QMS by Caliber Yes 

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 

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