Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Microsoft SharePoint
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
€8,500 one-time payment
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
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
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Learning Management Systems (LMS)
Academic / Education
No
Asynchronous Learning
No
Blended Learning
No
Built-In Course Authoring
No
Corporate / Business
No
Customizable
No
Gamification
No
Learner Portal
No
Mobile Learning
No
Open Source
No
SCORM Compliance
No
Synchronous Learning
No
Video Conferencing
No
eCommerce
No
eLearning Companies
No
LIMS
Audit Trail
No
Certificates of Analysis
No
Data Import / Export
No
Electronic Laboratory Notebook
No
Inventory Management
No
Lab Instrument Interface
No
Reporting & Statistics
No
Sample Tracking
No
Specification Management
No
Workflow Management
No
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No