Terms of Service

1. Agreement to Terms

These Terms of Service ("Terms") govern access to and use of the ComplianceWorxs platform, website, and related services (collectively, the "Services").

By accessing or using the Services, you agree to be bound by these Terms and all applicable laws and regulations.

If you do not agree to these Terms, you may not use the Services.

These Terms apply to all users, including visitors, subscribers, and organizations accessing the platform. If you are using ComplianceWorxs on behalf of an organization, you represent that you have authority to bind that entity to these Terms.

2. Description of Services

ComplianceWorxs provides an inspection intelligence and decision authorization platform designed to help regulated organizations understand and document compliance decisions in preparation for regulatory inspections.

The Services may include:

• inspection scenario libraries
• regulatory inspection intelligence
• inspection question references
• authorization assessments
• AI-assisted compliance documentation outputs
• structured decision authorization artifacts
• educational compliance materials

The Services are intended to assist organizations in documenting and understanding regulatory expectations but do not replace internal quality systems or regulatory oversight.

ComplianceWorxs is not a consulting firm, regulatory authority, or legal advisory service.

3. No Professional Advice

The Services do not constitute legal, regulatory, validation, or consulting advice.

Use of the Services does not create a consultant-client or advisory relationship.

Organizations remain solely responsible for determining how regulatory requirements apply to their operations and ensuring compliance with applicable laws and regulations.

4. Regulatory Outcome Disclaimer

ComplianceWorxs provides informational tools and documentation support intended to assist with compliance decision documentation.

ComplianceWorxs does not guarantee regulatory outcomes or inspection results.

Use of the Services does not ensure:

• inspection readiness
• regulatory approval
• absence of Form 483 observations
• avoidance of warning letters
• absence of enforcement actions

Regulatory agencies make independent determinations regarding compliance. ComplianceWorxs shall not be liable for regulatory findings including:

All regulatory determinations remain the responsibility of the regulated organization.

5. Client Responsibilities (GxP Compliance)

Users remain responsible for ensuring that their use of the Services complies with applicable regulatory requirements including GxP obligations.

Users must:

• verify the accuracy of information entered into the platform
• review all outputs generated by the Services
• ensure alignment with internal SOPs and quality systems
• maintain required documentation within their validated systems
• ensure personnel performing regulated activities are appropriately qualified

ComplianceWorxs does not replace an organization's internal quality management system.

6. GxP System Validation Responsibility

Organizations operating in regulated environments are responsible for determining whether the Services must be validated under their internal validation procedures.

ComplianceWorxs does not represent that the Services constitute a validated system within any customer's regulatory environment.

Each organization is responsible for determining validation requirements under:

• FDA 21 CFR Part 11
• EU Annex 11
• GAMP guidelines
• internal validation policies

7. AI-Assisted Outputs

The Services may generate AI-assisted outputs based on user inputs and system logic.

These outputs may include:

• inspection scenario explanations
• compliance analysis
• documentation templates
• decision authorization artifacts

AI-generated outputs may contain inaccuracies or omissions. All outputs must be reviewed and approved by qualified personnel before being used in regulated activities.

ComplianceWorxs makes no warranties regarding the completeness or regulatory sufficiency of AI-generated outputs.

8. Generated Compliance Artifacts

The platform may generate structured documentation artifacts based on user inputs.

These artifacts are informational tools intended to assist with documentation of compliance decisions. They should not be interpreted as:

• regulatory certifications
• validated regulatory records
• official regulatory documentation
• regulatory approvals

Organizations remain responsible for determining whether generated materials are appropriate for their regulatory environment.

9. Inspection Scenarios and Educational Content

Inspection scenarios, case studies, and regulatory explanations provided by the platform are educational materials derived from industry inspection patterns.

They are intended to illustrate regulatory expectations and do not represent:

• actual regulatory findings for specific organizations
• official regulatory interpretations
• guarantees of regulatory outcomes

10. Regulatory Interpretation Disclaimer

ComplianceWorxs does not provide official interpretations of regulatory requirements.

Regulatory agencies retain exclusive authority to interpret applicable regulations.

Users should consult qualified regulatory professionals when making compliance determinations.

11. Data Ownership and Confidentiality

Users retain ownership of data submitted to the platform.

ComplianceWorxs processes user data solely for the purpose of providing the Services.

ComplianceWorxs does not claim ownership of user-submitted compliance data.

Users should not submit confidential or proprietary regulatory documentation unless authorized to do so by their organization.

12. Security and Platform Availability

ComplianceWorxs implements commercially reasonable security measures designed to protect the Services.

However, no system can guarantee absolute security.

The Services are provided on an "as available" basis without guarantees of uninterrupted operation.

ComplianceWorxs will notify users of a confirmed security incident involving their data without undue delay and in accordance with applicable law.

13. Acceptable Use

Users agree not to:

• misuse the platform for unlawful purposes
• attempt to reverse engineer or interfere with system operation
• upload malicious or harmful data
• use the platform in violation of regulatory obligations

ComplianceWorxs may suspend access for violations of these Terms.

14. Intellectual Property

All platform software, content, and design elements are the intellectual property of ComplianceWorxs.

Users may not reproduce, distribute, or modify platform materials without permission.

Generated outputs may be used internally by the subscribing organization.

15. Indemnification

Client Indemnification

Users agree to indemnify and hold harmless ComplianceWorxs from claims arising from:

• misuse of the platform
• reliance on AI outputs without appropriate review
• regulatory enforcement actions related to user operations
• failure to comply with applicable regulatory requirements

This includes claims arising from regulatory inspections or investigations.

ComplianceWorxs Indemnification

ComplianceWorxs will indemnify users against third-party claims arising from a verified, confirmed data breach that is directly and solely attributable to ComplianceWorxs' negligence, provided that users promptly notify ComplianceWorxs in writing and cooperate fully in the defense of such claim.

16. Limitation of Liability

To the maximum extent permitted by law, ComplianceWorxs shall not be liable for:

• regulatory citations
• Form 483 observations
• warning letters
• enforcement actions
• inspection findings
• product recalls
• business interruption
• loss of revenue or profits

arising from use of the Services.

ComplianceWorxs' total cumulative liability shall not exceed the total fees paid by the user in the twelve (12) months immediately preceding the claim.

These limitations apply regardless of the theory of liability, whether in contract, tort, negligence, or otherwise, even if ComplianceWorxs has been advised of the possibility of such damages.

17. Subscription and Payment

Certain features of the Services may require payment of subscription fees.

Subscription terms, billing cycles, and cancellation policies are presented during account registration. Payments are processed through authorized payment providers.

ComplianceWorxs reserves the right to modify pricing upon 30 days' written notice. Continued use of the Services after a pricing change constitutes acceptance of the new pricing.

Either party may terminate for convenience with 30 days' written notice. Upon termination, client data will be retained for export for 90 days post-termination.

18. Export Control Compliance

Users agree to comply with all applicable export control laws and regulations when using the Services.

19. Force Majeure

ComplianceWorxs shall not be liable for failure to perform obligations due to events beyond its reasonable control, including natural disasters, infrastructure failures, or governmental actions.

20. Termination

ComplianceWorxs may suspend or terminate access to the Services if users violate these Terms.

Users may discontinue use of the Services at any time.

Upon termination, access ceases and client data will be retained for export for 90 days unless legally required otherwise.

21. Governing Law

These Terms shall be governed by the laws of the Commonwealth of Massachusetts, without regard to conflict of law principles.

All disputes arising from these Terms shall be resolved exclusively in the state and federal courts located in Massachusetts, and the parties consent to personal jurisdiction in those courts.

22. Changes to Terms

ComplianceWorxs may update these Terms from time to time by posting a revised version and updating the effective date.

Material changes will be communicated to active subscribers via email at least 30 days before they take effect.

Continued use of the Services constitutes acceptance of updated Terms.

23. Contact Information

For questions about these Terms, your account, or the Services:

• Legal: legal@complianceworxs.com
• Support: support@complianceworxs.com
• Security / Data Breach: security@complianceworxs.com