System overview & intended use
1. Purpose of this document
This document provides a high-level overview of Hoodin Compliance Studio and defines its intended use, scope, and boundaries.
The purpose of the document is to establish 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 provide regulatory advice, does not describe detailed system functionality, and does not replace customer-specific quality management procedures.
2. System overview
Hoodin Compliance Studio is a cloud-based Software as a Service (SaaS) platform designed to support regulatory intelligence, regulatory monitoring, and structured regulatory reasoning within life science organisations.
The system supports Regulatory Affairs and Quality Assurance (RA/QA) professionals by enabling them to:
identify and maintain awareness of applicable regulatory frameworks,
monitor regulatory changes across multiple jurisdictions,
structure regulatory information and reasoning over time,
document regulatory scope and related rationale in a consistent manner.
Hoodin Compliance Studio functions as a decision-support and information-structuring system. It does not execute regulated processes or replace professional regulatory judgement.
3. Intended users and organisational context
Hoodin Compliance Studio is intended for use by qualified professionals working within Regulatory Affairs, Quality Assurance, or closely related regulatory functions in life science organisations.
Typical user organisations include manufacturers, legal manufacturers, specification developers, and other entities subject to regulatory obligations under medical device, IVD, pharmaceutical, or biotech regulatory frameworks.
The system is not intended for use by patients, healthcare professionals in a clinical care context, or non-qualified personnel making regulatory decisions.
4. Intended use
The intended use of Hoodin Compliance Studio is to support the structured determination and maintenance of regulatory scope across products, organisations and markets.
Specifically, the system is intended to:
identify and propose applicable regulatory instruments based on defined product and organisational context
structure and document regulatory applicability together with supporting rationale
support review and verification of regulatory scope
maintain awareness of regulatory updates affecting the defined scope
The system supports informed regulatory decision-making by providing structured regulatory context and reasoning. All final regulatory decisions and compliance determinations remain the responsibility of the user organisation.
5. Explicit non-intended use
Hoodin Compliance Studio is explicitly not intended to:
perform regulatory decision-making or compliance determinations,
replace or act as a quality management system (QMS),
manage or approve regulated workflows such as design control, change control, CAPA, or batch release,
prepare, submit, or manage regulatory submissions or applications,
serve as a system of record for technical documentation or regulated quality records,
provide legal or regulatory advice.
Use of the system outside its defined intended use is the responsibility of the customer.
6. System boundaries and responsibility allocation
Hoodin is responsible for the development, operation, maintenance, and governance of the Hoodin Compliance Studio platform in accordance with its defined intended use.
Customers are responsible for:
determining how the system is used within their organisation,
validating the system for their specific intended use where required,
ensuring that regulatory conclusions and actions taken based on system outputs are appropriate and compliant.
Hoodin does not assume regulatory or legal responsibility for customer decisions or outcomes.
7. Relationship to regulatory frameworks
Hoodin Compliance Studio is designed to be used within organisations operating under regulatory frameworks such as EU MDR, EU IVDR, ISO 13485, EU GMP, FDA regulations, and similar regimes.
The system supports regulatory activities associated with these frameworks but does not itself constitute evidence of compliance. Its use does not remove or reduce the user organisation’s regulatory obligations.
8. Relationship to other governance documents
This document serves as the foundational reference for other governance and support documentation related to Hoodin Compliance Studio, including:
Where questions arise regarding scope, responsibility, or appropriate reliance on the system, this document should be consulted first.