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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.

Description

SetAIComply is a compliance platform designed specifically for small and medium-sized enterprises (SMEs) in Europe to navigate the EU AI Act, offering a cost-effective alternative to traditional enterprise governance, risk, and compliance (GRC) solutions that can range from €15k to €100k annually. Unlike typical GRC suites that merely integrate AI Act compliance with existing SOC 2 frameworks, SetAIComply is natively built for the AI Act and allows users to independently manage key tasks such as applicability scoping, risk classification per Annex III, and generating technical documentation as outlined in Annex IV through AI assistance. Furthermore, it provides essential tools like Data Protection Impact Assessments (DPIAs), a regulatory monitoring system, shadow AI detection, bias testing, and vendor management, all consolidated within a single workspace that supports all 24 official EU languages. The platform is fully hosted in Amsterdam, adheres to GDPR standards, and features end-to-end encryption along with a Data Processing Agreement (DPA) for added security. SetAIComply offers a genuinely free tier at €0, with self-service options available, and subscription plans starting at just €39 per month, making it accessible for SMEs aiming to comply with the evolving regulatory landscape. Additionally, this comprehensive solution simplifies the compliance journey, ensuring that businesses can focus on innovation while confidently managing their AI-related obligations.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

No images available

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint

Pricing Details

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

Pricing Details

€39/month
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

K2C

Country

United Kingdom

Website

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

Vendor Details

Company Name

SetAIComply

Founded

2026

Country

European Union

Website

www.setaicomply.com

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Product Features

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