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What is K2C PSMF Solution?

The K2C PSMF Solution introduces a groundbreaking approach to managing the Pharmacovigilance System Master File. It is crucial to periodically revise this document whenever significant changes occur in the pharmacovigilance protocols. These changes require input from multiple roles within the organization to modify a cohesive document that is structured according to regulatory guidelines. However, the process of coordinating these edits can be quite difficult, particularly because certain sections must be limited to designated editors and kept hidden from other contributors. To tackle this issue, the K2C solution treats each paragraph and annex as individual documents, making it easier to compile the final PSMF document by combining these various components. Furthermore, the K2C PSMF Solution manages contributions to the PSMF as separate entities, allowing for the control of access rights for both viewing and editing, while also providing thorough oversight of the entire document lifecycle, thereby ensuring compliance and efficiency throughout the entire process. This organized method not only improves collaboration among teams but also reinforces adherence to regulatory standards, ultimately enhancing the overall quality of the pharmacovigilance practices within the organization. As a result, the K2C PSMF Solution is an essential tool for organizations aiming to streamline their pharmacovigilance efforts.

What is AmpleLogic Document Management?

AmpleLogic EDMS Software stands out as a powerful electronic document management solution specifically designed for the Pharmaceutical and Biotech industries, adeptly meeting the cGMP standards while ensuring adherence to 21CFR Part 11 and EU Annex 11, thus tackling various obstacles these sectors frequently encounter. By offering a paperless approach to document management, it streamlines the organization and handling of all relevant documents and information, leading to improved efficiency. Among its key features are capabilities for document creation, review, approval, editing, comparison, version control, and parallel reviews, which collectively make it an essential resource for contemporary pharmaceutical operations. Additionally, the platform’s intuitive interface promotes teamwork and collaboration, allowing all team members to engage in document workflows effortlessly. This comprehensive system not only enhances operational productivity but also supports regulatory compliance, making it indispensable for businesses striving for excellence in the competitive pharmaceutical landscape.

Media

Media

No images available

Integrations Supported

AmpleLogic LCNC Platform
Microsoft SharePoint

Integrations Supported

AmpleLogic LCNC Platform
Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

€8,500 one-time payment
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

K2C

Company Location

United Kingdom

Company Website

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

Company Facts

Organization Name

AmpleLogic

Date Founded

2010

Company Location

India

Company Website

amplelogic.com

Categories and Features

Categories and 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

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