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Average Ratings 0 Ratings

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ease
features
design
support

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Description

AmpleLogic EDMS Software serves as a robust electronic document management solution tailored specifically for the Pharmaceutical and Biotech sectors, crafted to address the stringent cGMP requirements of the Pharma industry while ensuring compliance with both 21CFR Part 11 and EU Annex 11, effectively resolving the myriad challenges encountered by various organizations. This paperless document management system allows users to seamlessly manage and interact with all types of documents and information with ease. Key functionalities of the AmpleLogic Document Management System include document creation, review, approval, editing, document comparison, version control, and the ability to conduct parallel reviews, all designed to enhance operational efficiency and compliance. By integrating these features, AmpleLogic EDMS not only streamlines workflows but also significantly reduces the risk of errors in document handling.

Description

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

API Access

Has API

API Access

Has API

Screenshots View All

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Integrations

AmpleLogic LCNC Platform
Microsoft SharePoint

Integrations

AmpleLogic LCNC Platform
Microsoft SharePoint

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

€8,500 one-time payment
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

AmpleLogic

Founded

2010

Country

India

Website

amplelogic.com

Vendor Details

Company Name

K2C

Country

United Kingdom

Website

www.k2c.com/products/K2Pharma/PSMF.html

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

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