Quality Agreement — NoxReg

1. Purpose

This Quality Agreement is entered into between NoxReg (“Vendor”) and the subscribing organisation (“Customer”) and defines the quality responsibilities of each party with respect to the use of the NoxReg Regulatory Intelligence Platform in GxP-relevant activities, in accordance with ICH Q10.

2. Vendor Responsibilities (NoxReg)

• Maintain system availability of ≥99.9% monthly uptime (excluding scheduled maintenance)
• Notify Customer of material changes to AI model, classification schema, or agency coverage with minimum 14 calendar days advance notice
• Maintain AI generation logs for minimum 5 years
• Respond to security incidents within 24 hours
• Provide updated PSMF System Description upon request following material changes
• Maintain GDPR compliance for all data processing activities

3. Customer Responsibilities

• Perform User Acceptance Testing upon initial deployment and following material changes notified by NoxReg
• Document NoxReg in their Pharmacovigilance System Master File (where applicable) using the NoxReg PSMF System Description
• Ensure all AI-generated content is reviewed by a qualified regulatory professional before use in any regulated activity
• Maintain their own SOP for use of NoxReg in GxP-relevant processes
• Notify NoxReg of any identified AI errors via the in-application reporting mechanism

4. Change Management

NoxReg will issue change notifications for:

• AI model version updates
• Prompt version updates affecting classification logic
• Addition or removal of monitored agencies
• Changes to data retention policies
• Security incidents affecting Customer data

5. Audit Rights

Customer may request a vendor audit questionnaire response annually. On-site audits may be requested with 30 calendar days notice and are subject to NoxReg's audit policy.

6. Data Protection

Data processing is governed by the separate Data Processing Agreement. This Quality Agreement does not replace the DPA.

7. Term

This Agreement remains in effect for the duration of the Customer's active subscription to NoxReg.