1. Purpose of this document

This document provides a high-level overview of Compliance Studio and defines its intended use, scope and boundaries.

It establishes a common reference point for customers, auditors, procurement functions and internal stakeholders when assessing how the system is designed to be used and relied upon.

This document does not describe detailed system functionality and does not replace customer-specific quality management procedures or contractual terms.

2. System overview

Compliance Studio is a cloud-based Software as a Service (SaaS) platform for regulatory governance within life science organisations. It supports regulatory professionals in establishing and maintaining regulatory positions for products and companies across markets.

A Regulatory Position brings together a product or company, a selected market and the associated regulatory context. It provides a structured environment for identifying potentially applicable regulations, documenting applicability assessments and rationale, and reviewing relevant regulatory changes.

The system’s principal capabilities include:

• Regulations Register: structured management of regulatory scope, including proposed applicability, user assessments, supporting rationale and source references.

• Record Scout: supports discovery of potentially relevant regulatory instruments for review and inclusion in a Regulatory Position’s register.

• Provision Finder: supports identification of relevant provisions within a regulatory instrument, enabling users to examine specific requirements in the context of their Regulatory Position.

• Register Audit Trail: version history supporting traceability of changes to the register.

• Regulatory Signals: regulatory updates linked to the regulations within a position’s register, supporting review of potential consequences.

• Studio Agent: AI-supported regulatory exploration, analysis and planning using the available product or company, market and regulatory context.

• Collaboration: shared access and discussion supporting regulatory work within the customer organisation.
  

Studio Agent can assist with exploring regulatory pathways, structuring analyses, developing checklists and identifying questions requiring further investigation. Its outputs support professional review and do not constitute confirmed regulatory conclusions.

3. Intended users and organisational context

Compliance Studio is intended for professionals working within Regulatory Affairs, Quality Assurance and related regulatory functions, including consultants supporting life science organisations.

Typical user organisations include manufacturers, authorised representatives, importers, distributors, sponsors and other entities with regulatory responsibilities relating to medical devices, in vitro diagnostic medical devices, medicinal products, biotechnology products or combination products.

Users should have competence appropriate to their activities. Regulatory assessments and decisions must be reviewed by personnel with suitable expertise and authority within the customer organisation.

The system is not intended for clinical decision-making, diagnosis, treatment or use by patients.

4. Intended use

The intended use of Compliance Studio is to support regulatory professionals in establishing and maintaining regulatory positions for products and companies across markets, including during market-access planning and ongoing regulatory maintenance.

Specifically, the system is intended to:

• Identify and propose potentially applicable regulatory instruments based on defined product, company and market context.

• Structure and document regulatory scope, applicability assessments and supporting rationale.

• Support review of regulatory requirements and relevant source material.

• Assist with regulatory analysis and planning, including exploration of pathways, activities and information needs.

• Generate working materials, such as analyses and checklists, for professional review and adaptation.

• Monitor regulatory changes and support assessment of their implications within the relevant Regulatory Position.

• Support collaboration and traceability of documented regulatory assessments over time.

Compliance Studio provides decision support. AI-generated proposals and analyses require professional review before they are relied upon. The presence of a regulation in a register or an AI-generated response does not establish its applicability, completeness or correct interpretation.

Final regulatory decisions, compliance determinations and formal approvals remain the responsibility of the user organisation and, where applicable, the relevant authorities or conformity assessment bodies.

5. Explicit non-intended use

Compliance Studio is not intended to:

• Independently make or approve final regulatory decisions or compliance determinations.

• Replace a quality management system or the customer’s document control and approval procedures.

• Operate or approve processes such as design control, change control, CAPA, manufacturing or batch release.

• Act as a regulatory submission management system or submit applications to authorities or conformity assessment bodies.

• Replace the customer’s controlled repository for technical documentation, submission dossiers or quality records.

• Provide legal advice or binding regulatory interpretations.

• Guarantee complete regulatory coverage, market authorisation, certification or regulatory compliance.

Analyses and working materials produced within the system may support the preparation of regulatory documentation. Their suitability for any formal use must be assessed and approved through the customer’s applicable procedures.

6. System boundaries and responsibility allocation

Hoodin is responsible for the development, operation, maintenance and governance of Compliance Studio within its defined intended use and applicable contractual commitments.

Customers are responsible for:

• Determining whether the system is suitable for their intended organisational use.

• Providing and maintaining accurate product, company and market information.

• Assigning appropriate user access, responsibilities and review authority.

• Reviewing proposed applicability assessments, AI-generated content and regulatory signals against relevant sources.

• Resolving uncertainties and obtaining additional expertise where necessary.

• Determining and performing any qualification or validation activities required for their specific use.

• Incorporating relevant outputs into controlled processes and records where required.

• Approving