1. Purpose of this document

This document provides vendor-level information about Hoodin and Hoodin Compliance Studio to support procurement, legal, IT, and management reviews.

Its purpose is to enable an efficient and proportionate vendor assessment. It is not intended to describe product functionality in detail, define contractual terms, or replace customer-specific procurement or risk assessment processes.

2. Vendor identification

Legal entity

Hoodin AB

Role

Software provider of Hoodin Compliance Studio, a cloud-hosted regulatory intelligence and compliance support platform for life sciences organisations.

3. Product identification

Hoodin Compliance Studio is a Software as a Service (SaaS) platform designed to support regulatory intelligence, regulatory reasoning, and compliance-related governance activities within life sciences.

A detailed description of system scope, intended use, and limitations is defined in the System overview & intended use document and is not repeated here.

4. Delivery and deployment model

Hoodin Compliance Studio is provided as a cloud-hosted Software as a Service (SaaS) solution.

No local installation, customer-managed infrastructure, or client-side software components are required to access or use the system.

5. Data handling and processing principles

Hoodin Compliance Studio processes customer-provided configuration data and system usage information necessary to deliver the service.

The system is not intended to store or manage regulated production data, patient records, or controlled quality records.

Detailed information regarding data protection, privacy, and security controls is provided in separate documentation and contractual agreements where applicable.

6. Security and privacy posture

Hoodin applies appropriate organisational and technical measures to protect system availability, integrity, and confidentiality.

Security and privacy controls are implemented at vendor level and are maintained as part of Hoodin’s overall system governance.

This document does not provide a detailed security architecture or control catalogue.

7. Quality and governance positioning

Hoodin Compliance Studio is positioned as a regulatory support and decision-support system.

Hoodin maintains responsibility for system development, maintenance, change management, and release communication.

Customers remain responsible for regulatory decision-making, compliance assessments, and qualification of the system within their own organisational context.

8. Support, communication, and escalation

Hoodin provides structured support channels for customers and prospective customers.

General enquiries, procurement-related questions, and legal or contractual discussions can be initiated via: https://www.resources.hoodin.com/contact

Quality- and validation-related enquiries are handled separately to ensure appropriate routing and response.

9. Scope limitations

This document:

• does not define commercial terms, pricing, or licensing conditions,

• does not describe detailed system functionality,

• does not constitute a security whitepaper or validation report,

• does not replace contractual agreements or customer-specific assessments.