Acceptable Use Policy

1. Purpose

This Acceptable Use Policy ("AUP") governs your use of the ArvoDocs platform operated by ArvoDocs LLC. It is designed to protect our users, our infrastructure, and the integrity of quality management data.

2. Permitted Use

ArvoDocs is intended for legitimate quality management activities, including document control, quality event management, supplier management, training management, and related functions for medical device and regulated industry teams.

3. Prohibited Activities

You may not:

• • Use the Service for any unlawful purpose
• • Upload malicious code, viruses, or harmful content
• • Attempt to gain unauthorized access to other accounts or systems
• • Interfere with the operation of the Service or other users' access
• • Use the Service to store or transmit content that infringes intellectual property rights
• • Resell or redistribute the Service without authorization
• • Use automated tools to scrape, crawl, or excessively load the Service
• • Falsify quality records or audit data with intent to deceive regulators

4. Regulated Data and Compliance Restrictions

The following activities are specifically prohibited:

• • Storing PHI/ePHI without a BAA: You may not store protected health information (PHI) or electronic protected health information (ePHI) on the platform unless a Business Associate Agreement (BAA) is in place between your organization and ArvoDocs LLC. ArvoDocs is not HIPAA-covered by default. Contact legal@arvodocs.com to discuss BAA arrangements.
• • Regulatory submissions without validation: You may not use the platform to make regulatory submissions (e.g., FDA 510(k), CE marking technical files, PMA applications) without performing your own independent validation of all data, documents, and records. ArvoDocs is a tool designed to support your QMS — it is not a validated submission system and does not replace your obligation to verify and validate regulatory submissions.
• • Sharing login credentials: Each user must maintain unique login credentials. Sharing account passwords or authentication tokens between individuals is strictly prohibited. FDA 21 CFR Part 11 and EU Annex 11 require unique user identification for electronic record systems. Credential sharing undermines audit trail integrity and may constitute a regulatory violation.
• • Tampering with audit trail records: You may not attempt to modify, delete, overwrite, or circumvent audit trail records. The audit trail is immutable by design to support regulatory compliance. Any attempt to tamper with audit data is a serious violation of this policy and may be reported to relevant regulatory authorities.

5. Data Integrity

ArvoDocs is designed to maintain the integrity of quality management records. You are responsible for the accuracy and completeness of data you enter. The audit trail is immutable by design — attempts to circumvent audit logging are a violation of this policy.

6. Enforcement

We take violations of this AUP seriously. Enforcement actions are proportional to the severity and frequency of violations:

• • Warning: For first-time or minor violations, we will issue a written warning via email specifying the violation and required corrective action. You will be given a reasonable timeframe to remedy the issue.
• • Suspension: For repeated violations, failure to remedy after a warning, or serious violations that pose a risk to data integrity or other users, we may suspend your access to the Service. During suspension, your data remains intact but inaccessible until the issue is resolved.
• • Termination: For severe violations (including but not limited to: intentional falsification of quality records, deliberate audit trail tampering, or unlawful use of the Service), we may immediately terminate your account. Upon termination for cause, you will have 30 days to export your data.

Where immediate action is necessary to protect the Service, data integrity, or other users, we may suspend access without prior warning. In all cases, we will provide written explanation of the violation and the enforcement action taken.

7. Reporting

If you believe someone is violating this AUP, please contact us at abuse@arvodocs.com.