EU AI Act Compliance Statement

Last Updated: November 2025
Company: Validfor OÜ
Address: Harju maakond, Kesklinna linnaosa, Viru väljak 2, 3. korrus, Tallinn 10111, Estonia
Contact: compliance@validfor.com

Overview
This statement describes Validfor OÜ’s assessment and compliance position with respect to the European Union Artificial Intelligence Act (“EU AI Act”). Validfor provides Validation Lifecycle Management (VLM) software designed to digitalize and automate regulated documentation, traceability, and lifecycle activities in sectors such as pharmaceuticals, biotechnology, and medical devices.

Compliance Position
Validfor has conducted a comprehensive internal assessment of its operations, platform architecture, and AI-enabled functionalities against the scope and definitions of the EU AI Act.
Based on the results of this evaluation, Validfor’s core systems currently fall outside the scope of the EU AI Act’s regulatory framework.

Basis for Out-of-Scope Determination

  1. Safety Component Assessment
    Validfor’s systems do not perform any functions that qualify as “safety components” under Article 3(14) of the EU AI Act. Specifically:
  • Our software does not control, monitor, or replace safety mechanisms of regulated physical products.
  • Platform outputs do not directly affect the health, safety, or fundamental rights of individuals.
  • The Validfor platform does not interface with or govern equipment listed under Annex I, Section A of the EU AI Act (e.g., medical devices, machinery, or critical infrastructure systems).
  1. Product Classification
    Validfor’s Validation Lifecycle Management solution is a digital quality and documentation management system. It does not fall under any product category subject to CE marking or conformity assessment under sectoral legislation referenced in the EU AI Act.
    Accordingly, Validfor’s offerings are not classified within any of the regulated product categories, including but not limited to:
  • Machinery
  • Safety or control equipment
  • Medical devices
  • Personal protective equipment
  • Any other category listed under Annex I, Section A
  1. Risk Classification
    Following review of the risk taxonomy established by the EU AI Act, Validfor confirms that its systems:
  • Do not engage in or enable any prohibited AI practices as defined under Title II of the Act.
  • Do not qualify ashigh-risk AI systems, since their purpose is limited to document and workflow management.
  • Do not involve biometric identification, social scoring, or any function affecting individual rights or access to essential services.

Ongoing Compliance Monitoring
Although currently out of scope, Validfor maintains a proactive compliance strategy to ensure continuous monitoring of regulatory and technical developments related to the EU AI Act. In particular:

  • We conduct periodic internal audits and documentation reviews.
  • We monitor updates from the European Commission, AI Office, and national supervisory authorities.
  • We maintain detailed internal records of AI-related modules, risk assessments, and governance practices.
  • We will promptly adjust our policies and documentation should future product developments or regulatory interpretations bring any of our functionalities within scope.

Commitment to Responsible and Transparent AI
Validfor is committed to responsible technology development and to maintaining the trust of customers operating in regulated industries. Even where the EU AI Act does not apply, Validfor voluntarily adheres to core principles of ethical AI use, including:

  • Transparency and explainability in any AI-assisted functionality.
  • Human oversight and approval in all decision-support features.
  • Security, robustness, and auditability of AI-enabled components.
  • Full compliance with the EU GDPR and applicable data-protection legislation.
  • Continuous improvement of documentation and validation controls aligned with GAMP 5 and 21 CFR Part 11 principles.

Contact
For questions, audit requests, or clarifications regarding this EU AI Act Compliance Statement, please contact:
Compliance Team – compliance@validfor.com
Validfor OÜ
Harju maakond, Kesklinna linnaosa, Viru väljak 2, 3. korrus, Tallinn 10111, Estonia