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ease
features
design
support

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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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

EPIQ QMS by Caliber

Integrations

EPIQ QMS by Caliber

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

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
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
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

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