1. Agreement to Terms
These Terms of Service ("Terms") are a legally binding agreement between you and Socialize Commerce LLC DBA ComplianceWorxs ("we," "us," "our," or "ComplianceWorxs").
By accessing or using the Service (as defined below), or by clicking any button or checkbox presented with these Terms, you confirm that you have read, understood, and agree to be bound by these Terms. If you are using ComplianceWorxs on behalf of an organization, you represent that you have the authority to bind that entity to these Terms.
2. Nature of the Service (Important Clarification)
ComplianceWorxs does not provide traditional software as a Service (SaaS) alone.
ComplianceWorxs provides a compliance intelligence platform, decision support, and audit-readiness tools for regulatory compliance. The Service includes:
- Regulatory intelligence and structured compliance decision support
- Decision Defense Records (DDRs) with unique identifiers and frozen timestamps
- Audit-readiness tools including Audit Defense Briefs and Compliance Certificates
- AI-assisted analytics, traceability support, and monitoring utilities
The Service supports compliance activities but does not validate, certify, replace, approve, or guarantee the outcome of any regulatory decision, audit, or inspection.
ComplianceWorxs is a compliance tool, not a substitute for qualified regulatory professionals, qualified persons, or independent third-party quality auditors or compliance officers.
3. No Professional Advice; No Regulatory Guarantees
The Service does not constitute legal, regulatory, quality, scientific, or professional advice.
You acknowledge and agree that:
- Regulatory bodies (including FDA, EMA, MHRA, and comparable authorities) make independent decisions and are not bound by any output of ComplianceWorxs
- Use of the Service does not guarantee audit readiness, inspection success, or regulatory approval
- Compliance efforts, decisions, and outputs remain the responsibility of the client and its qualified personnel
- ComplianceWorxs does not constitute legal advice or replace the need for qualified legal counsel
4. Client Responsibilities (GxP and Validation)
You acknowledge and agree that:
- You are solely responsible for your own validation, or using all validation, CSV, and computerized system documentation per your SOPs
- You are responsible for ensuring proper use of DDRs, audit readiness processes, and compliance records
- Data you provide must be accurate, truthful, and maintained in accordance with your SOPs
- You understand the material and informational limitations of the Service
- You understand and accept the nature of AI-assisted outputs and use them accordingly (see Section 5)
ComplianceWorxs expressly disclaims responsibility for any validation performed outside of its control, or for failures to validate as required by applicable regulations.
5. AI Assisted Outputs and Risk Allocation
The Service may include AI-generated analytics and recommendations.
You acknowledge that:
- AI outputs may be incomplete, inaccurate, or incorrect
- AI is a tool, not a decision-maker
- Certain outputs may contain hallucinations or factual errors
- ComplianceWorxs does not warrant the accuracy of any AI-assisted or AI-generated output or analysis
You agree to treat AI-generated outputs as advisory inputs to, not substitutes for, qualified professional judgment. You are solely responsible for independently verifying all AI-assisted outputs before relying on them for any compliance, regulatory, or business decision.
6. Data Ownership, Processing, and Privacy
You retain ownership of all data you provide.
ComplianceWorxs:
- Processes data solely to provide the Service
- Stores data in federally secured cloud infrastructure
- Does not sell, rent, or share client data with third parties except as required to deliver the Service or as required by law
You are responsible for ensuring that appropriate data protection measures are maintained. Where described by law, a Data Processing Agreement (DPA) is incorporated by reference and governs personal data as a separate instrument.
7. Security Incidents and Breach Notification
ComplianceWorxs will notify you of a confirmed security incident involving your data without undue delay and in accordance with applicable law.
We will investigate the cause of any incident and implement appropriate remedial measures.
8. Indemnification
CLIENT INDEMNIFICATION
You agree to indemnify, defend, and hold harmless ComplianceWorxs from any claims, damages, fees, penalties, or regulatory enforcement actions arising from:
- Your use of the Service
- Your regulatory, validation, or compliance decisions
- Reliance on the Service as a substitute for qualified professional judgment
- Failure to maintain regulatory compliance
- Violation of these Terms or applicable regulations
COMPLIANCEWORKXS INDEMNIFICATION
ComplianceWorxs will indemnify you against third-party claims arising from a verified, confirmed data breach that is directly and solely attributable to ComplianceWorxs' negligence, provided that you promptly notify ComplianceWorxs in writing and cooperate fully in the defense of such claim.
9. Limitation of Liability
To the maximum extent permitted by law:
- ComplianceWorxs' total cumulative liability shall not exceed the total fees paid by you in the twelve (12) months immediately preceding the claim
- ComplianceWorxs shall not be liable for indirect, incidental, consequential, special, or punitive damages
- In no circumstances shall ComplianceWorxs be liable for regulatory penalties, inspection outcomes, lost revenue, lost data, or findings, recalls, or business interruption
These limitations apply regardless of the theory of liability, whether in contract, tort, negligence, strict liability, or otherwise, even if ComplianceWorxs has been advised of the possibility of such damages.
10. Subscription, Fees, and Payment
Subscription terms and associated fees are defined in your selected tier or invoice.
Unless otherwise specified, subscriptions are billed monthly in advance. All fees are non-refundable except as required by applicable law. Failure to pay may result in suspension of access to the Service.
ComplianceWorxs reserves the right to modify pricing upon 30 days' written notice. Continued use of the Service after a pricing change constitutes acceptance of the new pricing.
11. Termination
Either party may terminate:
- For convenience with 30 days' written notice
- For material breach if not cured within 30 days of written notice
Upon termination:
- Access ceases
- Client data will be retained for export for 90 days post-termination
- Your obligation to pay for services rendered prior to termination survives
- Records are accessible for 90 days unless legally required otherwise
12. Governing Law and Jurisdiction
These Terms are governed by the laws of the Commonwealth of Massachusetts, without regard to conflict of law principles.
All disputes shall be resolved exclusively in the state and federal courts located in Massachusetts, and the parties consent to personal jurisdiction in those courts.
Arbitration and other alternative dispute resolution methods may be available upon mutual written agreement of the parties.
13. Changes to Terms
We may update these Terms at any time by posting a revised version on our website and updating the effective date. Material changes will be communicated to active subscribers via email at least 30 days before they take effect.
Your continued use of the Service following any changes to these Terms constitutes your acceptance of the revised Terms. If you do not agree to the revised Terms, you must discontinue use of the Service and notify us of your intent to terminate.
14. Contact Information
For questions about these Terms, your account, or the Service:
- Legal: legal@complianceworxs.com
- Support: support@complianceworxs.com
- Emergency (security/data breach): security@complianceworxs.com