Terms of Service

1. Agreement to Terms

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

By accessing this website, purchasing a case file, or using any feature of the Services, you agree to be fully and unconditionally bound by these Terms and all applicable laws and regulations.

If you are using ComplianceWorxs on behalf of an organization, you represent and warrant that you have full authority to bind that organization to these Terms, and that the organization agrees to these Terms.

2. Description of Services

ComplianceWorxs provides decision-specific case file products and a decision authorization platform designed to help regulated life sciences organizations understand and document compliance decisions.

The Services may include:

• Scenario-specific case files ($149 per file)
• Inspection scenario libraries and educational content
• Regulatory inspection intelligence and question references
• AI-assisted compliance documentation outputs
• Structured decision authorization artifacts
• Authorization assessment tools

3. No Professional Advice

Nothing in the Services constitutes legal, regulatory, validation, or compliance consulting advice.

Use of the Services does not create a consultant-client, attorney-client, or advisory relationship of any kind.

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

4. Regulatory Outcome Disclaimer

ComplianceWorxs provides informational tools and documentation support. ComplianceWorxs makes no representations and provides no guarantees regarding regulatory outcomes or inspection results of any kind.

Use of the Services does not ensure or imply:

• Inspection readiness or a clean inspection outcome
• Regulatory approval of any product, process, or submission
• Absence of Form 483 observations
• Avoidance of warning letters or enforcement actions
• Compliance with any specific regulatory requirement

5. Client Responsibilities

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

Users must:

• Verify the accuracy of all information entered into the platform
• Review and approve all outputs generated by the Services before use in regulated activities
• Ensure alignment with internal SOPs and quality systems
• Maintain required documentation within their own validated systems
• Ensure personnel performing regulated activities are appropriately qualified
• Obtain appropriate internal authorization before submitting any organizational data to the platform

6. GxP System Validation Responsibility

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

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 and SOPs

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, and decision authorization artifacts.

ComplianceWorxs does not permit customer data to be used to train public AI models.

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 must not be interpreted as:

• Regulatory certifications of any kind
• Validated regulatory records
• Official regulatory documentation
• Regulatory approvals or determinations

Organizations remain solely responsible for determining whether generated materials are appropriate for their regulatory environment and for any use made of those materials.

9. Inspection Scenarios and Educational Content

Case files, inspection scenarios, 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, or guarantees of any regulatory outcome.

10. Regulatory Interpretation Disclaimer

ComplianceWorxs does not provide official interpretations of regulatory requirements. Regulatory agencies retain exclusive authority to interpret applicable regulations. Users must consult qualified regulatory professionals when making compliance determinations of regulatory significance.

11. Data Ownership and Confidentiality

Users retain full ownership of data submitted to the platform. ComplianceWorxs processes user data solely for the purpose of providing the Services and does not claim ownership of user-submitted data.

Confidentiality Obligations

ComplianceWorxs agrees to treat all user-submitted data as confidential and will not disclose it to third parties except as required to deliver the Services, as required by law, or with the express written consent of the user.

Users must not submit data they are not authorized to share. By submitting data to the platform, users represent and warrant that they have all necessary rights and authorizations to do so.

User Confidentiality Obligations

Users agree to maintain the confidentiality of any non-public platform features, pricing, or proprietary methodologies they encounter through use of the Services. Users may not disclose, reproduce, or share platform content, case file content, or proprietary methodologies with third parties without express written permission from ComplianceWorxs.

12. Security and Platform Availability

ComplianceWorxs implements commercially reasonable security measures designed to protect the Services and user data, including encryption in transit, controlled access, and infrastructure monitoring.

The Services are provided on an "as available" basis without guarantees of uninterrupted operation. No system can guarantee absolute security.

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:

• Use the platform for any unlawful purpose or in violation of any applicable law or regulation
• Attempt to reverse engineer, decompile, or interfere with platform systems or security
• Upload malicious code, harmful data, or unauthorized content
• Use the platform to facilitate fraud, misrepresentation, or deception
• Attempt to gain unauthorized access to any system, account, or data
• Resell, sublicense, or commercialize platform outputs without express written permission
• Use the platform in a manner that could damage the reputation or interests of ComplianceWorxs

ComplianceWorxs reserves the right to immediately suspend or terminate access without notice for violations of these Terms.

14. Intellectual Property

All platform software, case file content, scenario content, methodologies, design elements, and brand assets are the exclusive intellectual property of ComplianceWorxs and are protected by applicable copyright, trademark, and intellectual property laws.

Users may not reproduce, distribute, modify, publicly display, or create derivative works from platform materials without express written permission from ComplianceWorxs.

Generated outputs may be used internally by the purchasing organization for their own compliance documentation purposes only. They may not be resold, redistributed, or used commercially.

15. Indemnification

User Indemnification of ComplianceWorxs

Users agree to fully indemnify, defend, and hold harmless ComplianceWorxs, its officers, directors, employees, and agents from and against any and all claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees) arising from or related to:

• Misuse of the platform or violation of these Terms
• Reliance on AI-generated outputs without appropriate independent review
• Any regulatory enforcement action related to user operations
• Failure to comply with applicable regulatory requirements
• Submission of data the user was not authorized to share
• Breach of confidentiality obligations under these Terms
• Any third-party claim arising from the user's use of platform outputs
• Any unauthorized disclosure of proprietary platform content or methodologies
• Any claim arising from the user's violation of applicable export control laws

ComplianceWorxs Indemnification of Users

ComplianceWorxs will indemnify users against direct third-party claims arising solely and directly from:

• A verified data breach directly and solely attributable to ComplianceWorxs' gross negligence or willful misconduct
• Unauthorized disclosure of user-submitted confidential data by ComplianceWorxs to third parties outside the scope of these Terms
• A verified breach of ComplianceWorxs' own confidentiality obligations under these Terms

This indemnification is conditioned upon the user promptly notifying ComplianceWorxs in writing of any such claim, cooperating fully in the defense of the claim, and granting ComplianceWorxs sole control over the defense and settlement of the claim.

Technology Breach Indemnification

In the event of a confirmed technology breach directly attributable to ComplianceWorxs' infrastructure failures or gross negligence, ComplianceWorxs will indemnify affected users for direct, documented losses resulting from unauthorized access to their submitted data, subject to the limitation of liability provisions in Section 16. Users must take all reasonable steps to mitigate losses and must cooperate fully with any investigation.

16. Limitation of Liability

To the maximum extent permitted by applicable law, ComplianceWorxs shall not be liable for any indirect, incidental, consequential, special, or punitive damages, including but not limited to:

• Regulatory citations, Form 483 observations, or warning letters
• Enforcement actions, consent decrees, or import alerts
• Inspection findings or product recalls
• Business interruption or loss of revenue
• Loss of profits, goodwill, or anticipated savings
• Data loss or corruption beyond ComplianceWorxs' reasonable control

ComplianceWorxs' total cumulative liability for any claim arising from or related to these Terms or the Services 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, strict liability, or otherwise — even if ComplianceWorxs has been advised of the possibility of such damages.

17. Case Files and Payment

Case file products are available for individual purchase at the price displayed at the time of purchase. All purchases are processed through Stripe. ComplianceWorxs does not store payment card data.

Case file purchases are non-refundable once access to the case file content has been provided. If you experience a technical issue preventing access, contact support@complianceworxs.com within 48 hours of purchase.

ComplianceWorxs reserves the right to modify pricing at any time. Price changes will not affect purchases already completed.

Where subscription services are offered, terms, billing cycles, and cancellation policies will be presented at the time of subscription. Either party may terminate a subscription with 30 days' written notice. Upon termination, user data will be retained for export for 90 days.

18. Export Control

Users agree to comply with all applicable export control laws and regulations when using the Services. Users represent that they are not located in a jurisdiction subject to U.S. trade embargo or on any U.S. government restricted party list.

19. Force Majeure

ComplianceWorxs shall not be liable for any failure or delay in performing its obligations under these Terms where such failure or delay results from events beyond its reasonable control, including natural disasters, infrastructure failures, cyberattacks beyond ComplianceWorxs' reasonable control, governmental actions, pandemics, or other force majeure events.

20. Termination

ComplianceWorxs may immediately suspend or terminate access to the Services without notice if users violate these Terms, engage in fraudulent or harmful conduct, or misuse the platform in any way.

Users may discontinue use of the Services at any time. Upon termination, access to the Services ceases and user data will be retained for export for 90 days unless legally required otherwise.

Provisions of these Terms that by their nature should survive termination — including confidentiality, indemnification, intellectual property, limitation of liability, and governing law — shall survive termination.

21. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Florida, without regard to conflict of law principles.

All disputes arising from or related to these Terms or the Services shall be resolved exclusively in the state and federal courts located in Sarasota County, Florida, and the parties irrevocably 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 after the effective date of any changes constitutes unconditional acceptance of the updated Terms. If you do not agree to updated Terms, you must immediately cease use of the Services.

23. Contact Information

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