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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

GxPLABS specializes in delivering a wide range of digital software solutions designed to support industries with stringent regulatory and quality requirements. Their product portfolio covers SOP and document management, learning management, electronic lab notebooks, lab information systems, quality management systems, and other specialized modules like CAPA, audit, risk, and calibration management. Built on a low code and AI-powered platform, GxPLABS ensures platform independence and device compatibility for flexible implementation. The solutions are fully compliant with major industry regulations including 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001. With over a decade of experience and a client base spanning 10+ countries, GxPLABS offers expert support and customizable options tailored to complex business challenges. Their offerings also include paperless validation, electronic batch manufacturing records, and case processing systems, enabling digitization and automation. Companies can leverage GxPLABS to streamline operations, enhance compliance, and improve data integrity. The company emphasizes flexible pricing and unique technological approaches to meet diverse client needs.

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

No images available

Screenshots View All

Integrations

Microsoft SharePoint

Integrations

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

GxPLABS

Founded

2018

Country

India

Website

www.gxplabs.com

Vendor Details

Company Name

K2C

Country

United Kingdom

Website

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

Product Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

ELN

Learning Management Systems (LMS)

Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Corporate / Business
Customizable
Gamification
Learner Portal
Mobile Learning
Open Source
SCORM Compliance
Synchronous Learning
Video Conferencing
eCommerce
eLearning Companies

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management

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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