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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
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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