Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
GoVal is an AI-powered validation software purpose-built to digitize the full validation lifecycle across pharma, biotech, medical device, and other life science industries. From Computer System Validation (CSV), Equipment Qualification, and various validation requirements to broader GxP compliance needs, it leverages intelligent automation to deliver streamlined digital workflows—all within a secure, paperless framework.
Its customizable platform with role-based workflows enables automated reviews, approvals, and real-time visibility, backed by compliant e-signatures and audit-ready traceability. Built to meet 21 CFR Part 11, EU Annex 11, and leading GxP standards, GoVal ensures seamless regulatory alignment. Risk-based strategies at the URS level empower teams to drive targeted mitigation planning and precise test case design.
GoVal AI goes further—accelerating validation timelines through generative assistance for risk assessments, documentation, and test development. An in-built Document Management System (DMS) allows users to securely store, organize, and retrieve validation documents as needed—supporting data integrity, traceability, and effortless access during audits.
Integrated deviation management, change tracking, and continuously updated data simplify inspections while reducing manual errors. The result: faster deployment, lower compliance costs, and stronger ROI—delivered with clarity, control, and continuous compliance.
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
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
Yes
iPad App
No
Android App
Yes
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
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
AdventSys Technologies
Founded
2015
Country
India
Website
www.govalidation.com
Vendor Details
Company Name
K2C
Country
United Kingdom
Website
www.k2c.com/products/K2Pharma/PSMF.html
Product Features
Scientific Data Management System (SDMS)
Analytics
No
Artificial Intelligence (AI)
Yes
Audit
Yes
Centralized Data Repository
Yes
Collaboration
Yes
Compliance
Yes
Data Security
Yes
ELN Integration
Yes
LIMS Integration
No
Workflows
Yes