REGULATORY QMSR replaces 21 CFR Part 820 — is your quality system ready? Check your gaps free →
Legal

Terms of Service

Your agreement with Aligntra for using our compliance platform

Last updated: April 9, 2026

Agreement to Our Legal Terms

We are Aligntra Inc. (“Company,” “we,” “us,” “our”).

We operate the website www.aligntra.com, as well as any other related products and services that refer or link to these legal terms (the “Legal Terms”) (collectively, the “Services”).

Aligntra is an AI-powered regulatory compliance platform that analyzes quality management system documents against international standards and regulatory frameworks. Users can upload documents, run automated compliance audits, generate reports, verify records against standard operating procedures, and manage their organization’s quality documentation.

You can contact us by email at legal@aligntra.com or by mail to Aligntra Inc., Wilmington, DE 19808, United States.

These Legal Terms constitute a legally binding agreement made between you, whether personally or on behalf of an entity (“you”), and Aligntra Inc., concerning your access to and use of the Services. You agree that by accessing the Services, you have read, understood, and agreed to be bound by all of these Legal Terms. IF YOU DO NOT AGREE WITH ALL OF THESE LEGAL TERMS, THEN YOU ARE EXPRESSLY PROHIBITED FROM USING THE SERVICES AND YOU MUST DISCONTINUE USE IMMEDIATELY.

Supplemental terms and conditions or documents that may be posted on the Services from time to time are hereby expressly incorporated herein by reference. We reserve the right, in our sole discretion, to make changes or modifications to these Legal Terms at any time and for any reason. We will alert you about any changes by updating the “Last updated” date of these Legal Terms, and you waive any right to receive specific notice of each such change. It is your responsibility to periodically review these Legal Terms to stay informed of updates. You will be subject to, and will be deemed to have been made aware of and to have accepted, the changes in any revised Legal Terms by your continued use of the Services after the date such revised Legal Terms are posted.

Table of Contents

  1. Our Services
  2. Nature of the Services — Tools Only
  3. Intellectual Property Rights
  4. User Representations
  5. Prohibited Activities
  6. Use on Behalf of Third Parties
  7. User Generated Contributions
  8. Contribution License
  9. Services Management
  10. Subscription and Billing
  11. AI-Powered Analysis Disclaimer
  12. Document Confidentiality and Data Processing
  13. Privacy Policy
  14. Term and Termination
  15. Modifications and Interruptions
  16. Governing Law
  17. Dispute Resolution
  18. Corrections
  19. Disclaimer
  20. Limitations of Liability
  21. Indemnification
  22. User Data
  23. Electronic Communications, Transactions, and Signatures
  24. Force Majeure
  25. Export Controls and Sanctions
  26. Acceptable Use and Fair Use
  27. Miscellaneous
  28. Contact Us

1. Our Services

Aligntra provides an AI-powered compliance automation platform that analyzes documents against regulatory standards including, but not limited to, ISO 13485, ISO 9001, AS9100D, FDA QMSR, EU MDR, MDSAP, and ISO 14971. Our Services include:

The information provided when using the Services is not intended for distribution to or use by any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject us to any registration requirement within such jurisdiction or country. Accordingly, those persons who choose to access the Services from other locations do so on their own initiative and are solely responsible for compliance with local laws, if and to the extent local laws are applicable.

2. Nature of the Services — Tools Only

Aligntra is a software platform, not a professional services firm

Aligntra Inc. is a software technology company. We are not a registered auditing body, certification body, notified body, regulatory consultancy, law firm, or professional services organization. We do not hold any ISO/IEC 17021, ISO/IEC 17065, or equivalent accreditation, and we do not conduct audits as defined by ISO 19011:2018. Aligntra does not employ or represent certified lead auditors, regulatory affairs professionals, or legal counsel acting on your behalf.

Tools for assisting you — responsibility remains with you

Aligntra will have no liability or responsibility for your compliance programs, and the Services, to the extent applicable, are only tools for assisting you in meeting the various compliance obligations for which you solely are responsible. The use of the Services and any information or outputs generated by them is intended to serve as a supplement to, and not a substitute for, the knowledge, expertise, skill, and judgment of qualified individuals within your industry.

Not a medical device

Aligntra is a software tool for quality management workflow support. It is not a medical device, is not cleared, approved, or certified by the FDA or any other regulatory authority, and is not intended for use in clinical decision-making, diagnosis, treatment, prevention, or mitigation of disease. Aligntra does not qualify as Software as a Medical Device (SaMD) under FDA guidance, EU MDR Regulation 2017/745, or any other regulatory framework.

Analysis Outputs are not audit reports or certifications

Reports, exports, compliance matrices, gap analyses, executive summaries, readiness assessments, and any other content generated by the Services (collectively, “Analysis Outputs”) are automated AI-assisted working documents. Analysis Outputs are not audit reports as defined by ISO 19011:2018, are not certificates of conformity, and do not represent the findings of a certified auditor, notified body, or regulatory authority. You must not represent Analysis Outputs to any third party — including regulators, certification bodies, customers, or auditors — as the findings of a qualified human auditor or as evidence that a formal audit has been conducted. If you share Analysis Outputs with any third party, you do so at your own risk and on your own responsibility.

3. Intellectual Property Rights

Our intellectual property

We are the owner or the licensee of all intellectual property rights in our Services, including all source code, databases, functionality, software, website designs, audio, video, text, photographs, and graphics in the Services (collectively, the “Content”), as well as the trademarks, service marks, and logos contained therein (the “Marks”).

Our Content and Marks are protected by copyright and trademark laws and treaties around the world.

The Content and Marks are provided in or through the Services “AS IS” for your internal business purpose only.

Your use of our Services

Subject to your compliance with these Legal Terms, including the “Prohibited Activities” and “Use on Behalf of Third Parties” sections below, we grant you a non-exclusive, non-transferable, revocable license to:

solely for your own organization’s internal business purposes, or on behalf of clients subject to the conditions set out in Section 6 (Use on Behalf of Third Parties).

Except as set out in this section or elsewhere in our Legal Terms, no part of the Services and no Content or Marks may be copied, reproduced, aggregated, republished, uploaded, posted, publicly displayed, encoded, translated, transmitted, distributed, sold, licensed, or otherwise exploited for any commercial purpose whatsoever, without our express prior written permission.

If you wish to make any use of the Services, Content, or Marks other than as set out in this section or elsewhere in our Legal Terms, please address your request to: legal@aligntra.com.

We reserve all rights not expressly granted to you in and to the Services, Content, and Marks.

Any breach of these Intellectual Property Rights will constitute a material breach of our Legal Terms and your right to use our Services will terminate immediately.

Your submissions

Please review this section and the “Prohibited Activities” section carefully prior to using our Services to understand the (a) rights you give us and (b) obligations you have when you post or upload any content through the Services.

Submissions: By directly sending us any question, comment, suggestion, idea, feedback, or other information about the Services (“Submissions”), you agree to assign to us all intellectual property rights in such Submission. You agree that we shall own this Submission and be entitled to its unrestricted use and dissemination for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you.

Uploaded Documents: For the avoidance of doubt, documents you upload for compliance analysis (SOPs, records, policies, work instructions, and other quality management system documents) are not Submissions. You retain full ownership of your uploaded documents. See “User Generated Contributions” and “Document Confidentiality and Data Processing” for terms governing uploaded documents.

You are responsible for what you post or upload: By sending us Submissions through any part of the Services you:

You are solely responsible for your Submissions and you expressly agree to reimburse us for any and all losses that we may suffer because of your breach of (a) this section, (b) any third party’s intellectual property rights, or (c) applicable law.

4. User Representations

By using the Services, you represent and warrant that:

If you provide any information that is untrue, inaccurate, not current, or incomplete, we have the right to suspend or terminate your account and refuse any and all current or future use of the Services (or any portion thereof).

5. Prohibited Activities

You may not access or use the Services for any purpose other than that for which we make the Services available. The Services may not be used in connection with any commercial endeavors except those that are specifically endorsed or approved by us.

As a user of the Services, you agree not to:

6. Use on Behalf of Third Parties

Permitted scope of use

These Legal Terms authorize use of the Services by you and your authorized users for your own organization’s internal business purposes. If you are a consultant, regulatory advisor, managed service provider, or professional services firm, you may also use the Services on behalf of your clients (“Client Use”), provided that all of the following conditions are met:

Client Use that does not satisfy all of the above conditions is a material breach of these Legal Terms and may result in immediate suspension or termination of your account.

What these Legal Terms do not cover

These Legal Terms govern the relationship between Aligntra and you. No client or other third party is a beneficiary of, or acquires any rights under, these Legal Terms. Aligntra has no duty, obligation, or liability to any client or third party who receives or relies upon Analysis Outputs generated through your account.

Your responsibility for Client Use

When you use the Services on behalf of a client, you are solely responsible for: (a) obtaining and maintaining all necessary client authorizations; (b) the accuracy and suitability of any Analysis Outputs you deliver to your client; (c) any instructions, representations, or warranties you make to your client regarding the Services or any Analysis Outputs; and (d) your client’s compliance with applicable law. Aligntra’s liability in connection with Client Use is limited solely to its obligations to you under these Legal Terms and does not extend to your clients.

Indemnification for third-party use

Without limiting Section 21 (Indemnification), if you engage in Client Use, you agree to defend, indemnify, and hold Aligntra harmless from any and all claims, losses, liabilities, damages, and expenses (including reasonable attorneys’ fees) brought by your clients or any other third party arising from or relating to: (i) your failure to obtain required client authorizations; (ii) your misrepresentation of the nature or reliability of Analysis Outputs; (iii) your client’s use of or reliance on Analysis Outputs; or (iv) any other act or omission by you in connection with Client Use.

7. User Generated Contributions

The Services allow you to upload, submit, store, and process documents and related content, including but not limited to standard operating procedures (SOPs), quality records, policies, work instructions, manuals, forms, and evidence documents (collectively, “Contributions”). These Contributions are processed solely to provide you with compliance analysis and related Services.

Unlike public-facing user-generated content platforms, your Contributions are not publicly viewable and are not shared with other users or organizations. Your Contributions are accessible only to authorized members of your organization as configured within your account settings.

When you upload or make available any Contributions, you thereby represent and warrant that:

8. Contribution License

By uploading Contributions to the Services, you grant us a limited, non-exclusive, worldwide, royalty-free license to access, store, process, analyze, and use your Contributions solely for the purpose of providing, maintaining, and improving the Services to you and your organization. This license includes the right to process your documents through third-party AI service providers as described in the “AI-Powered Analysis Disclaimer” section.

By submitting suggestions or other feedback regarding the Services, you agree that we can use and share such feedback for any purpose without compensation to you.

We do not assert any ownership over your Contributions. You retain full ownership of all of your Contributions and any intellectual property rights or other proprietary rights associated with your Contributions. We are not liable for any statements or representations in your Contributions provided by you in any area on the Services. You are solely responsible for your Contributions to the Services and you expressly agree to exonerate us from any and all responsibility and to refrain from any legal action against us regarding your Contributions.

No AI Training: We do not use your Contributions (uploaded documents) to train, fine-tune, or improve artificial intelligence or machine learning models. Your documents are processed solely to generate analysis results for your use.

Ownership of Analysis Outputs: Analysis Outputs generated by the Services from your uploaded Contributions (including compliance reports, gap analyses, RCV results, executive summaries, and export files) are owned by you. Aligntra retains no ownership interest in Analysis Outputs generated for your account. Documents generated by the SOP Builder based on your inputs are also owned by you, subject to applicable third-party AI provider terms. Aligntra claims no ownership over Analysis Outputs and will not use them for any purpose other than providing the Services to you.

9. Services Management

We reserve the right, but not the obligation, to: (1) monitor the Services for violations of these Legal Terms; (2) take appropriate legal action against anyone who, in our sole discretion, violates the law or these Legal Terms, including without limitation, reporting such user to law enforcement authorities; (3) in our sole discretion and without limitation, refuse, restrict access to, limit the availability of, or disable (to the extent technologically feasible) any of your Contributions or any portion thereof; (4) in our sole discretion and without limitation, notice, or liability, to remove from the Services or otherwise disable all files and content that are excessive in size or are in any way burdensome to our systems; and (5) otherwise manage the Services in a manner designed to protect our rights and property and to facilitate the proper functioning of the Services.

10. Subscription and Billing

Plans and pricing

Aligntra offers various subscription plans (including Trial, Professional, Business, and Enterprise tiers) with different features, usage limits, and pricing. Current pricing and plan details are available on our pricing page. We reserve the right to modify plan features and pricing at any time, subject to the notice provisions below.

Authorization for recurring charges

By providing a payment method and subscribing to a paid plan, you expressly authorize Aligntra to charge your payment method on a recurring basis at the then-current rate for your chosen subscription plan, plus applicable taxes, until you cancel your subscription or your account is otherwise terminated. For monthly plans, your payment method will be charged each month on or about the date you first subscribed. For annual plans, your payment method will be charged for the full year upfront at the applicable annual rate. This authorization remains in effect until you cancel through the methods described below.

Billing and payment

All subscriptions are processed through our third-party payment processor, Stripe. You agree to provide current, complete, and accurate billing information and to promptly update such information as necessary. All fees are stated in US Dollars unless otherwise indicated. You are responsible for all applicable taxes, levies, or duties imposed by taxing authorities in connection with your subscription, and Aligntra will charge tax as required by law.

Service delivery acknowledgment

You acknowledge that the Services are delivered electronically. Access to the platform constitutes delivery of the Services for the applicable subscription period. Your use of the Services after any billing date — including logging in, uploading documents, running analyses, accessing reports, or any other interaction with the platform — constitutes your acknowledgment that the Services have been delivered as described and are functioning as intended for that billing period.

Auto-renewal

YOUR SUBSCRIPTION WILL AUTOMATICALLY RENEW at the end of each billing period (monthly or annually, as applicable) at the then-current rate unless you cancel before the renewal date. For annual subscriptions, we will send a renewal reminder at least thirty (30) days before the renewal date to the email address associated with your account. It is your responsibility to ensure your contact information is current. Continued use of the Services after any renewal date constitutes your acceptance of the renewed subscription and associated charges.

Trial services — evaluation only, provided “as-is”

We may offer a trial period for new users with limited functionality and usage allowances (“Trial Services”). Trial Services are provided solely for the purpose of evaluating the Services before committing to a paid subscription.

TRIAL SERVICES ARE PROVIDED “AS-IS” AND “AS-AVAILABLE” WITHOUT ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. ALIGNTRA SHALL HAVE NO INDEMNIFICATION OBLIGATIONS NOR LIABILITY OF ANY TYPE WITH RESPECT TO TRIAL SERVICES OR ANY OUTPUTS GENERATED DURING THE TRIAL PERIOD. ANALYSIS OUTPUTS GENERATED DURING A TRIAL PERIOD ARE FOR EVALUATION PURPOSES ONLY AND MUST NOT BE RELIED UPON FOR ACTUAL REGULATORY COMPLIANCE DECISIONS, AUDIT PREPARATION, REGULATORY SUBMISSIONS, OR CLIENT DELIVERABLES. CLIENT USE (AS DEFINED IN SECTION 6) IS EXPRESSLY PROHIBITED DURING THE TRIAL PERIOD. TRIAL OUTPUTS MUST NOT BE DELIVERED TO OR RELIED UPON BY ANY THIRD PARTY.

Any documents, analysis results, or other customer information that you provide or make available to Aligntra during a trial period will be permanently deleted within 30 days after the trial period ends if you do not purchase a subscription. We strongly recommend that you export any data you wish to retain before your trial expires.

If you provide a payment method during sign-up, your payment method will be automatically charged the applicable subscription fee at the end of the trial period unless you cancel before the trial expires. We will send a reminder email at least 7 days before your trial ends, specifying the exact plan name and amount that will be charged. If you do not provide a payment method, your account will revert to a limited trial tier at the end of the trial period. We reserve the right to modify or discontinue trial offers at any time.

Refund policy

All fees are non-refundable except as expressly stated in this section or as required by applicable law. No refunds or credits will be issued for: (a) partial subscription periods, (b) periods during which you did not use the Services, (c) downgrades to a lower-tier plan, or (d) early termination of an annual subscription. In limited circumstances, we may, at our sole discretion, issue refunds or credits for annual subscriptions cancelled within the first fourteen (14) days of the initial subscription term, provided you have not run any compliance analyses during that period. Refund requests must be submitted to billing@aligntra.com.

Cancellation

You may cancel your subscription at any time through your account settings or by contacting billing@aligntra.com. Cancellation takes effect at the end of the current billing period. You will retain access to the Services at your current plan level until the end of the period you have already paid for. After the current billing period ends, your account will revert to the trial tier with limited functionality. Cancellation does not entitle you to a refund for the current or any prior billing period.

Price changes

We may change our pricing with at least thirty (30) days’ prior notice sent to your account email address. Price changes will apply to your next billing cycle following the notice period. If you do not agree with a price change, you may cancel your subscription before the change takes effect. Continued use of the Services after the price change takes effect constitutes your acceptance of the new pricing.

Failed payments

If a payment fails, we will attempt to process the payment again in accordance with our payment processor’s retry schedule. We will notify you of the failed payment by email. If payment remains unsuccessful after multiple attempts, we may suspend or downgrade your account until the payment issue is resolved. You remain responsible for all outstanding amounts owed, including any fees that accrued during the period of failed payment.

Billing disputes — contact us first

If you believe any charge is incorrect, you must contact us at billing@aligntra.com within thirty (30) days of the charge. We will work with you in good faith to resolve the dispute. You agree to attempt to resolve any billing dispute directly with Aligntra before initiating a chargeback, payment dispute, or reversal with your bank, credit card company, or payment provider.

Filing a chargeback or payment dispute with your financial institution without first contacting Aligntra and allowing a reasonable period (at least fifteen (15) business days) to resolve the dispute constitutes a material breach of this Agreement. In such event, Aligntra reserves the right to: (a) immediately suspend your access to the Services; (b) pursue collection of all amounts owed, including the disputed amount; and (c) charge a dispute processing fee of twenty-five US dollars ($25.00) per dispute to cover administrative and payment processor costs. This fee will be charged to your payment method on file or collected through other lawful means.

If a dispute is resolved in your favor, we will promptly issue the appropriate refund or credit and waive any dispute processing fee. Suspension of your account due to a billing dispute does not relieve you of your payment obligations for undisputed amounts.

Right to suspend for payment issues

Aligntra reserves the right to immediately suspend or limit your access to the Services upon: (a) receipt of a chargeback or payment dispute notification from our payment processor; (b) failure to pay any undisputed amounts when due after written notice; or (c) reasonable suspicion of payment fraud or unauthorized use of a payment method. Access will be restored upon resolution of the issue and payment of all outstanding amounts, including any applicable fees.

11. AI-Powered Analysis Disclaimer

This section contains critical information about the nature of our Services. Please read it carefully.

No warranty of AI outputs

ALIGNTRA MAKES NO COVENANTS, REPRESENTATIONS, OR WARRANTIES REGARDING ANY OUTPUTS GENERATED, TRANSMITTED, OR MADE AVAILABLE IN CONNECTION WITH YOUR USE OF AI FEATURES OF THE SERVICES (“AI OUTPUTS”), INCLUDING, WITHOUT LIMITATION, WITH RESPECT TO THE ACCURACY, QUALITY, COMPLETENESS, OR TRUTHFULNESS THEREOF. Before leveraging any AI Outputs in any manner, you and your authorized users are responsible for making your own determination that the AI Outputs are suitable for your intended use, and you are solely responsible for any reliance on the accuracy, completeness, or usefulness of any AI Outputs.

Regulated industry limitations

THE SERVICES ARE NOT WARRANTED TO SATISFY THE REQUIREMENTS OF ANY SPECIFIC REGULATORY AUTHORITY, NOTIFIED BODY, ACCREDITATION BODY, OR CERTIFICATION BODY, INCLUDING WITHOUT LIMITATION THE U.S. FOOD AND DRUG ADMINISTRATION, THE EUROPEAN MEDICINES AGENCY, EASA, OR ANY ISO CERTIFICATION BODY. Aligntra has not been validated as a compliant electronic records system under 21 CFR Part 11, EU Annex 11, or equivalent regulations governing electronic records in regulated industries. Analysis Outputs stored within the Services should not be considered validated electronic records for regulatory submission purposes.

SOP Builder outputs

Documents generated by the SOP Builder or other document generation features are AI-assisted drafts only. They must be reviewed, validated, and approved by qualified personnel within your organization before being incorporated into your quality management system as controlled documents. We make no representation that AI-generated documents are free from third-party intellectual property claims, including claims by standards bodies asserting copyright in the text of regulatory standards.

EU AI Act

Aligntra’s AI-powered analysis features are designed as decision-support tools requiring human oversight and review. Aligntra does not make automated decisions with legal or similarly significant effects on individuals. You are responsible for human review of all AI-generated outputs before acting on them, consistent with applicable AI regulatory frameworks.

Probabilistic nature; similar outputs across customers

Due to the nature of machine learning, AI Outputs may not be unique, and the Services may generate the same or similar AI Outputs for Aligntra or a third party in response to similar inputs. Given the probabilistic nature of machine learning, the Services may in some situations produce AI Outputs that are inaccurate, incorrect, incomplete, or otherwise undesirable. You acknowledge that identical or similar inputs may produce different AI Outputs at different times.

Absence of findings does not indicate compliance

If the Services do not identify a non-conformance, gap, or deficiency for a particular regulatory clause, section, or requirement, this does not mean you are compliant with that requirement. AI analysis may fail to detect non-conformances due to limitations in document content, ambiguity in regulatory language, model limitations, or incomplete document uploads. A favorable compliance score or “audit ready” assessment is an AI-generated estimate, not a certification of compliance. You must independently verify compliance through your own quality management processes, internal audits, and, where appropriate, engagement of qualified regulatory professionals.

Decision-support tool, not professional advice

Aligntra’s compliance analysis results are provided as decision-support tools only. Our Services are not a substitute for professional regulatory advice, legal counsel, certified auditing services, or expert human judgment. Analysis results do not constitute legal or regulatory advice, a professional audit opinion, or a guarantee of regulatory compliance.

AI technology and third-party providers

Our Services use artificial intelligence and large language models (LLMs) provided by third-party AI service providers, including but not limited to Anthropic (via AWS Bedrock). When you upload documents for analysis, the content of those documents is transmitted to these AI service providers for processing. By using our Services, you consent to this processing.

No guarantee of accuracy or completeness

While we strive for accuracy, AI-powered analysis is inherently probabilistic. Results may contain errors, omissions, or inaccuracies. Regulatory standards and their interpretations evolve over time, and our AI models may not reflect the most recent regulatory updates or interpretive guidance at any given moment. You are responsible for:

No AI training on your data

We do not use your uploaded documents or analysis results to train, fine-tune, or improve AI models. Your documents are processed on a per-request basis solely to generate compliance analysis results for your use. Our AI service providers are contractually prohibited from using your data for model training purposes.

12. Document Confidentiality and Data Processing

Confidential treatment

We understand that the documents you upload to the Services may contain sensitive and proprietary information about your organization’s quality management system, processes, and compliance status. We treat all uploaded documents as confidential information and will not disclose them to third parties except as necessary to provide the Services (i.e., processing by our AI service providers) or as required by law.

Data storage and security

Your documents and analysis results are stored in cloud object storage (Cloudflare R2) with organization-level isolation. Each organization’s data is logically separated using organization-scoped storage paths and access controls, and is accessible only to authorized members of that organization as configured within your account settings.

We implement the following security measures to protect your data:

While we take reasonable measures to protect your data, no method of electronic storage or transmission is 100% secure. We cannot guarantee absolute security of your data.

Security breach notification

In the event of a confirmed security breach that affects your data, we will notify you within 72 hours of our confirmation of the breach to the email address associated with your account. Our notification will include, to the extent known at the time: the nature of the breach, the categories of data affected, the approximate number of records involved, and the remediation steps we have taken or plan to take. Where notification to a supervisory authority or data subjects is required by applicable law (including GDPR Article 33), we will fulfill those obligations within the legally required timeframes.

Sub-processors

In order to provide the Services, we use the following categories of sub-processors that may process your data:

We maintain contractual data processing agreements with our sub-processors that require them to protect your data in accordance with applicable data protection laws. We will update this list as sub-processors change, and a current list is available upon request at legal@aligntra.com.

Data residency

Our primary data storage and processing infrastructure is located in the United States. If your organization has specific data residency requirements, please contact us to discuss available options.

Data Processing Agreement

Enterprise customers requiring a formal Data Processing Agreement (DPA) for GDPR or other data protection compliance may request one by contacting legal@aligntra.com.

13. Privacy Policy

We care about data privacy and security. Please review our Privacy Policy. By using the Services, you agree to be bound by our Privacy Policy, which is incorporated into these Legal Terms. Please be advised the Services are hosted in the United States. If you access the Services from any other region of the world with laws or other requirements governing personal data collection, use, or disclosure that differ from applicable laws in the United States, then through your continued use of the Services, you are transferring your data to the United States, and you expressly consent to have your data transferred to and processed in the United States.

We also use cookies and similar tracking technologies as described in our Cookie Policy.

14. Term and Termination

These Legal Terms shall remain in full force and effect while you use the Services.

Termination for cause

We may terminate or suspend your account immediately, without prior notice or liability, for cause, including without limitation: breach of these Legal Terms, non-payment of applicable fees, fraud, illegal activity, or use of the Services in a manner that poses a security risk to us or other users. In such cases, no refund of prepaid subscription fees will be provided. If we terminate or suspend your account for cause, you are prohibited from registering a new account without our prior written consent.

Termination for convenience by Aligntra

Except in cases of termination for cause, if we elect to terminate an active paid subscription account for convenience (i.e., for reasons other than breach, fraud, or non-payment), we will provide at least 30 days’ prior written notice to the email address associated with your account (or 90 days for annual plan subscribers). Upon such termination, we will issue a pro-rata refund of any prepaid but unused subscription fees for the period following the termination effective date.

Termination of trial and free accounts

We reserve the right to terminate trial or free accounts at any time, at our sole discretion, without notice or liability.

In addition to terminating or suspending your account, we reserve the right to take appropriate legal action, including without limitation pursuing civil, criminal, and injunctive redress.

Data export upon termination

Upon termination of your account (whether by you or by us, except in cases of termination for fraud or illegal activity), we will use commercially reasonable efforts to maintain access to your data for a period of 30 days from the date of termination, during which you may export your documents and analysis results using the export features available within the Services (including per-audit PDF and Excel exports, and individual document downloads).

After this 30-day period, we will initiate deletion of your data from our active production systems. Data may persist in encrypted form in backup or archival systems for up to an additional 90 days, after which it will be removed as part of routine storage rotation. We may retain certain data as required by applicable law or for legitimate business purposes (such as fraud prevention, billing records, and legal compliance), in which case such data will be retained only for the legally required period.

We strongly recommend that you export all documents and reports before cancelling your subscription or before the end of any termination notice period. We are not obligated to provide data export assistance beyond the self-service tools available within the platform, though Enterprise customers may contact support@aligntra.com for assisted data migration.

15. Modifications and Interruptions

Material changes to these Legal Terms

For material changes to these Legal Terms — including changes to pricing, liability limitations, arbitration terms, data processing practices, or the scope of permitted use — we will provide at least 30 days’ prior written notice to the email address associated with your account before such changes take effect. If you do not agree to a material change, you may terminate your subscription without penalty before the effective date of the change by contacting billing@aligntra.com. Your continued use of the Services after the effective date constitutes acceptance of the updated Legal Terms.

Non-material changes (such as corrections, clarifications, and additions that do not reduce your rights) may be made at any time and will be reflected by an updated “Last updated” date at the top of these Legal Terms.

Service modifications and interruptions

We reserve the right to change, modify, or remove the contents of the Services at any time or for any reason at our sole discretion without notice. However, we have no obligation to update any information on our Services. We will not be liable to you or any third party for any modification, price change, suspension, or discontinuance of the Services.

We cannot guarantee the Services will be available at all times. We may experience hardware, software, or other problems or need to perform maintenance related to the Services, resulting in interruptions, delays, or errors. We reserve the right to change, revise, update, suspend, discontinue, or otherwise modify the Services at any time or for any reason without notice to you. You agree that we have no liability whatsoever for any loss, damage, or inconvenience caused by your inability to access or use the Services during any downtime or discontinuance of the Services. Nothing in these Legal Terms will be construed to obligate us to maintain and support the Services or to supply any corrections, updates, or releases in connection therewith.

16. Governing Law

These Legal Terms shall be governed by and defined following the laws of the State of Delaware, United States, without regard to its conflict of law principles. Aligntra Inc. and yourself irrevocably consent that the courts of the State of Delaware shall have exclusive jurisdiction to resolve any dispute which may arise in connection with these Legal Terms, except as otherwise provided in the “Dispute Resolution” section below.

17. Dispute Resolution

Informal negotiations

To expedite resolution and control the cost of any dispute, controversy, or claim related to these Legal Terms (each a “Dispute” and collectively, the “Disputes”) brought by either you or us (individually, a “Party” and collectively, the “Parties”), the Parties agree to first attempt to negotiate any Dispute (except those Disputes expressly provided below) informally for at least 30 days before initiating arbitration. Such informal negotiations commence upon written notice from one Party to the other Party.

Binding arbitration

If the Parties are unable to resolve a Dispute through informal negotiations, the Dispute (except those Disputes expressly excluded below) will be finally and exclusively resolved by binding arbitration. YOU UNDERSTAND THAT WITHOUT THIS PROVISION, YOU WOULD HAVE THE RIGHT TO SUE IN COURT AND HAVE A JURY TRIAL.

The arbitration shall be commenced and conducted under the Commercial Arbitration Rules of the American Arbitration Association (“AAA”). The number of arbitrators shall be one (1). The seat, or legal place, of arbitration shall be Wilmington, Delaware. The language of the proceedings shall be English. The governing law of these Legal Terms shall be the substantive law of the State of Delaware.

The arbitrator’s award shall be binding and may be entered as a judgment in any court of competent jurisdiction. The Parties shall share the costs of arbitration equally, except that each Party shall bear its own attorneys’ fees unless the arbitrator determines that a Party’s claims or defenses were frivolous, in which case the arbitrator may award reasonable attorneys’ fees to the prevailing Party.

Restrictions

Geographic carve-out

Notwithstanding the foregoing arbitration provisions, customers located in the European Union, United Kingdom, Canada, or Australia retain the right to bring claims before their local courts of competent jurisdiction in lieu of arbitration, where mandatory arbitration is prohibited or restricted by applicable local law.

Small claims

Either party may bring an individual action in small claims court for disputes within that court’s jurisdictional limits, without requiring informal negotiation or arbitration.

Class action waiver

The Parties agree that any arbitration shall be limited to the Dispute between the Parties individually. To the full extent permitted by law: (a) no arbitration shall be joined with any other proceeding; (b) there is no right or authority for any Dispute to be arbitrated on a class-action basis or to utilize class action procedures; and (c) there is no right or authority for any Dispute to be brought in a purported representative capacity on behalf of the general public or any other persons.

Exceptions to informal negotiations and arbitration

The Parties agree that the following Disputes are not subject to the above provisions concerning informal negotiations and binding arbitration: (a) any Disputes seeking to enforce or protect, or concerning the validity of, any of the intellectual property rights of a Party; (b) any Dispute related to, or arising from, allegations of theft, piracy, invasion of privacy, or unauthorized use; and (c) any claim for injunctive relief. If this provision is found to be illegal or unenforceable, then neither Party will elect to arbitrate any Dispute falling within that portion of this provision found to be illegal or unenforceable and such Dispute shall be decided by a court of competent jurisdiction within the courts listed for jurisdiction above, and the Parties agree to submit to the personal jurisdiction of that court.

18. Corrections

There may be information on the Services that contains typographical errors, inaccuracies, or omissions, including descriptions, pricing, availability, and various other information. We reserve the right to correct any errors, inaccuracies, or omissions and to change or update the information on the Services at any time, without prior notice.

19. Disclaimer

THE SERVICES ARE PROVIDED ON AN AS-IS AND AS-AVAILABLE BASIS. YOU AGREE THAT YOUR USE OF THE SERVICES WILL BE AT YOUR SOLE RISK. TO THE FULLEST EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, IN CONNECTION WITH THE SERVICES AND YOUR USE THEREOF, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WE MAKE NO WARRANTIES OR REPRESENTATIONS ABOUT THE ACCURACY OR COMPLETENESS OF THE SERVICES' CONTENT OR THE CONTENT OF ANY WEBSITES LINKED TO THE SERVICES AND WE WILL ASSUME NO LIABILITY OR RESPONSIBILITY FOR ANY (1) ERRORS, MISTAKES, OR INACCURACIES OF CONTENT AND MATERIALS, (2) PERSONAL INJURY OR PROPERTY DAMAGE, OF ANY NATURE WHATSOEVER, RESULTING FROM YOUR ACCESS TO AND USE OF THE SERVICES, (3) ANY UNAUTHORIZED ACCESS TO OR USE OF OUR SECURE SERVERS AND/OR ANY AND ALL PERSONAL INFORMATION AND/OR FINANCIAL INFORMATION STORED THEREIN, (4) ANY INTERRUPTION OR CESSATION OF TRANSMISSION TO OR FROM THE SERVICES, (5) ANY BUGS, VIRUSES, TROJAN HORSES, OR THE LIKE WHICH MAY BE TRANSMITTED TO OR THROUGH THE SERVICES BY ANY THIRD PARTY, AND/OR (6) ANY ERRORS OR OMISSIONS IN ANY CONTENT AND MATERIALS OR FOR ANY LOSS OR DAMAGE OF ANY KIND INCURRED AS A RESULT OF THE USE OF ANY CONTENT POSTED, TRANSMITTED, OR OTHERWISE MADE AVAILABLE VIA THE SERVICES.

WITHOUT LIMITING THE FOREGOING, NEITHER WE NOR OUR LICENSORS WARRANT THAT (A) THE COMPLIANCE ANALYSIS RESULTS, FINDINGS, OR RECOMMENDATIONS GENERATED BY THE SERVICES ARE ACCURATE, COMPLETE, RELIABLE, OR ERROR-FREE; (B) THE SERVICES REFLECT THE MOST CURRENT VERSION OF ANY REGULATORY STANDARD OR INTERPRETIVE GUIDANCE; (C) USE OF THE SERVICES WILL RESULT IN COMPLIANCE WITH ANY REGULATORY STANDARD, LAW, OR REQUIREMENT; OR (D) THE SERVICES WILL SATISFY ANY THIRD-PARTY AUDIT, INSPECTION, OR CERTIFICATION REQUIREMENT. YOU ACKNOWLEDGE THAT AI-POWERED ANALYSIS IS PROBABILISTIC IN NATURE AND MAY PRODUCE DIFFERENT RESULTS FOR THE SAME INPUT UNDER DIFFERENT CONDITIONS.

20. Limitations of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL WE OR OUR DIRECTORS, EMPLOYEES, OR AGENTS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, CONSEQUENTIAL, EXEMPLARY, INCIDENTAL, SPECIAL, OR PUNITIVE DAMAGES, INCLUDING LOST PROFIT, LOST REVENUE, LOSS OF DATA, BUSINESS INTERRUPTION, OR OTHER INTANGIBLE LOSSES ARISING FROM YOUR USE OF THE SERVICES, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

WITHOUT LIMITING THE FOREGOING, IN NO EVENT SHALL WE BE LIABLE FOR ANY DAMAGES ARISING FROM OR RELATED TO: (A) ANY REGULATORY NON-COMPLIANCE, AUDIT FAILURE, INSPECTION FINDING, OR ENFORCEMENT ACTION, REGARDLESS OF WHETHER YOU RELIED ON THE SERVICES IN PREPARING FOR SUCH AUDIT OR INSPECTION; (B) ANY DECISION MADE OR ACTION TAKEN BY YOU OR YOUR ORGANIZATION IN RELIANCE ON ANALYSIS RESULTS GENERATED BY THE SERVICES; (C) ANY INACCURACY, OMISSION, OR ERROR IN THE AI-POWERED ANALYSIS OR RECOMMENDATIONS PROVIDED BY THE SERVICES; OR (D) ANY THIRD-PARTY ACTIONS, INCLUDING ACTIONS BY OUR SUB-PROCESSORS, AI SERVICE PROVIDERS, OR CLOUD INFRASTRUCTURE PROVIDERS.

NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, OUR TOTAL AGGREGATE LIABILITY TO YOU FOR ALL CLAIMS ARISING OUT OF OR RELATED TO THESE LEGAL TERMS OR YOUR USE OF THE SERVICES, REGARDLESS OF THE FORM OF THE ACTION (WHETHER IN CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE), WILL AT ALL TIMES BE LIMITED TO THE GREATER OF: (A) THE AMOUNT PAID, IF ANY, BY YOU TO US DURING THE TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE CLAIM; OR (B) FIVE HUNDRED US DOLLARS ($500.00). THIS LIMITATION APPLIES TO ALL CLAIMS IN THE AGGREGATE, NOT PER INCIDENT.

YOU ACKNOWLEDGE THAT AI-POWERED COMPLIANCE ANALYSIS IS SUBJECT TO INHERENT LIMITATIONS, INCLUDING THE RISK OF INACCURATE, INCOMPLETE, OR MISLEADING OUTPUTS. ALIGNTRA’S TOTAL LIABILITY FOR ANY REGULATORY ENFORCEMENT ACTION, AUDIT FAILURE, OR COMPLIANCE CONSEQUENCE ARISING FROM RELIANCE ON AI OUTPUTS SHALL NOT EXCEED THE AGGREGATE LIABILITY CAP SET FORTH ABOVE, REGARDLESS OF THE FORM OF ACTION AND WHETHER OR NOT ALIGNTRA HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENCE.

CERTAIN US STATE LAWS AND INTERNATIONAL LAWS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR THE EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IF THESE LAWS APPLY TO YOU, SOME OR ALL OF THE ABOVE DISCLAIMERS OR LIMITATIONS MAY NOT APPLY TO YOU, AND YOU MAY HAVE ADDITIONAL RIGHTS.

21. Indemnification

You agree to defend, indemnify, and hold us harmless, including our subsidiaries, affiliates, and all of our respective officers, agents, partners, and employees, from and against any loss, damage, liability, claim, or demand, including reasonable attorneys’ fees and expenses, made by any third party due to or arising out of:

Notwithstanding the foregoing, we reserve the right, at your expense, to assume the exclusive defense and control of any matter for which you are required to indemnify us, and you agree to cooperate, at your expense, with our defense of such claims. We will use reasonable efforts to notify you of any such claim, action, or proceeding which is subject to this indemnification upon becoming aware of it.

Aligntra’s indemnification of you

Aligntra will defend, indemnify, and hold you harmless from any third-party claims alleging that the core Aligntra platform (excluding your uploaded Contributions and Analysis Outputs derived therefrom) infringes a third party’s intellectual property rights, provided that: (a) you promptly notify Aligntra of the claim in writing; (b) you grant Aligntra sole control of the defense and settlement; and (c) you cooperate reasonably with Aligntra’s defense. Aligntra’s indemnification obligations under this section are subject to the aggregate liability cap in Section 20 and do not apply to claims arising from your modification of the Services, your Contributions, or your use of the Services in breach of these Legal Terms.

22. User Data

We will maintain certain data that you transmit to the Services for the purpose of managing the performance of the Services, as well as data relating to your use of the Services. You are solely responsible for all data that you transmit or that relates to any activity you have undertaken using the Services. While we store your data on reliable cloud infrastructure with built-in redundancy provided by our storage providers, we do not guarantee that data loss will never occur. You agree that we shall have no liability to you for any loss or corruption of any such data, and you hereby waive any right of action against us arising from any such loss or corruption of such data.

We strongly recommend that you maintain your own copies of all documents uploaded to the Services and all analysis reports generated by the Services. The Services should not be used as your sole or primary repository for critical compliance documentation. You should regularly export your analysis results and retain copies of all uploaded documents in your own systems.

Regulated industry record retention: If you operate in a regulated industry with mandatory record retention requirements (such as medical device, pharmaceutical, or aerospace), you must independently maintain copies of all Analysis Outputs and uploaded documents in your own validated systems. Aligntra is not a validated quality record repository and cannot serve as your system of record for regulatory compliance purposes. Aligntra does not maintain regulated audit trails as defined under 21 CFR Part 11, ISO 13485:2016 §4.2.5, or equivalent regulations. You are solely responsible for maintaining compliant quality records, including any records that reference or incorporate Analysis Outputs. We strongly recommend exporting all data before cancelling your subscription. The 30-day post-termination export window described in Section 14 may be insufficient for organizations with long-term regulatory retention obligations.

23. Electronic Communications, Transactions, and Signatures

Visiting the Services, sending us emails, and completing online forms constitute electronic communications. You consent to receive electronic communications, and you agree that all agreements, notices, disclosures, and other communications we provide to you electronically, via email and on the Services, satisfy any legal requirement that such communication be in writing. YOU HEREBY AGREE TO THE USE OF ELECTRONIC SIGNATURES, CONTRACTS, ORDERS, AND OTHER RECORDS, AND TO ELECTRONIC DELIVERY OF NOTICES, POLICIES, AND RECORDS OF TRANSACTIONS INITIATED OR COMPLETED BY US OR VIA THE SERVICES. You hereby waive any rights or requirements under any statutes, regulations, rules, ordinances, or other laws in any jurisdiction which require an original signature or delivery or retention of non-electronic records, or to payments or the granting of credits by any means other than electronic means.

24. Force Majeure

Neither party shall be liable for any failure or delay in performing its obligations under these Legal Terms (other than payment obligations) where such failure or delay results from circumstances beyond the affected party’s reasonable control, including but not limited to: acts of God, natural disasters, pandemics or epidemics, war, terrorism, riots, embargoes, acts of civil or military authorities, fire, floods, earthquakes, accidents, strikes or labor disputes, disruptions to power grids or telecommunications networks, cyberattacks, failures of third-party cloud infrastructure providers (including but not limited to AWS, Cloudflare, and Railway), government actions or regulations, or any other event beyond the reasonable control of the affected party (“Force Majeure Event”).

The affected party shall provide notice to the other party as soon as reasonably practicable after becoming aware of a Force Majeure Event and shall use commercially reasonable efforts to mitigate its effects. If a Force Majeure Event continues for more than sixty (60) consecutive days, either party may terminate these Legal Terms upon written notice to the other party, without liability for such termination.

25. Export Controls and Sanctions

The Services may be subject to export control and sanctions laws and regulations of the United States and other jurisdictions, including the Export Administration Regulations (EAR) and programs administered by the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC). By using the Services, you represent and warrant that: (a) you are not located in, organized under the laws of, or a resident of any country or territory that is the subject of comprehensive U.S. sanctions (currently Cuba, Iran, North Korea, Syria, and the Crimea, Donetsk, and Luhansk regions of Ukraine); (b) you are not identified on any U.S. government restricted party list, including the Specially Designated Nationals and Blocked Persons List (SDN List) or the Entity List; and (c) you will not use the Services in violation of any applicable export control or sanctions laws.

You are solely responsible for ensuring that your use of the Services complies with all applicable export control and sanctions laws in your jurisdiction.

26. Acceptable Use and Fair Use

In addition to the Prohibited Activities described in Section 4, the Services are subject to fair use limitations designed to ensure equitable access for all users. Your subscription plan includes usage allowances for compliance analyses, document uploads, and other platform features as described on our pricing page.

You agree not to: (a) use the Services in a manner that exceeds the usage allowances of your subscription plan through automated scripts, bots, or other programmatic means, except through our documented APIs; (b) share account credentials across organizations or provide access to individuals outside your authorized organization; (c) use the Services to perform competitive benchmarking or analysis of Aligntra’s AI models, algorithms, or methodologies without our prior written consent; or (d) place unreasonable or disproportionate load on our infrastructure, as determined by us in our reasonable discretion.

If we determine that your usage exceeds the fair use limits of your plan or is adversely affecting the availability or performance of the Services for other users, we will notify you and work with you to resolve the issue. If the issue is not resolved within a reasonable period, we may throttle, suspend, or upgrade your account to an appropriate plan level.

27. Miscellaneous

These Legal Terms and any policies or operating rules posted by us on the Services or in respect to the Services constitute the entire agreement and understanding between you and us, and supersede all prior and contemporaneous oral or written understandings, representations, negotiations, and communications relating to the Services, including any statements made by our sales or marketing representatives. Our failure to exercise or enforce any right or provision of these Legal Terms shall not operate as a waiver of such right or provision. These Legal Terms operate to the fullest extent permissible by law. We may assign any or all of our rights and obligations to others at any time. If any provision or part of a provision of these Legal Terms is determined to be unlawful, void, or unenforceable, that provision or part of the provision is deemed severable from these Legal Terms and does not affect the validity and enforceability of any remaining provisions. There is no joint venture, partnership, employment, or agency relationship created between you and us as a result of these Legal Terms or use of the Services. You agree that these Legal Terms will not be construed against us by virtue of having drafted them. You hereby waive any and all defenses you may have based on the electronic form of these Legal Terms and the lack of signing by the parties hereto to execute these Legal Terms.

Survival

The following sections shall survive termination or expiration of these Legal Terms for any reason: Sections 3 (Intellectual Property Rights), 6 (Use on Behalf of Third Parties — indemnification obligations), 8 (Contribution License — ownership and no AI training), 17 (Dispute Resolution), 19 (Disclaimer), 20 (Limitations of Liability), 21 (Indemnification), 22 (User Data), 25 (Export Controls and Sanctions), and this Section 27.

No third-party beneficiaries

These Legal Terms are for the exclusive benefit of the parties hereto and their permitted successors and assigns. No third party is or shall be deemed a beneficiary of these Legal Terms. No third party, including any client, customer, regulator, notified body, or auditor of yours, acquires any rights against Aligntra by reason of these Legal Terms or by reliance on any Analysis Outputs generated hereunder.

Enterprise agreements

Enterprise customers may enter into a separate Master Service Agreement or Order Form with Aligntra. In the event of a conflict between such a written and signed agreement and these Legal Terms on a matter addressed in that agreement, the Master Service Agreement or Order Form shall control; these Legal Terms shall control for all other matters. Partner-tier accounts are governed by these Legal Terms and any applicable supplemental partner terms communicated at account setup.

Seat limits

Your subscription plan specifies the maximum number of authorized users permitted to access the Services. Adding users beyond your plan’s limit may result in a required upgrade to an appropriate plan tier. You are responsible for ensuring that usage within your organization remains within your plan’s limits.

Supplier qualification

Aligntra does not provide Computer System Validation (CSV) or Computer Software Assurance (CSA) documentation as a standard service offering. If your organization requires software supplier qualification documentation (such as security questionnaire responses or a system description for regulatory or procurement purposes), please contact support@aligntra.com.

28. Contact Us

In order to resolve a complaint regarding the Services or to receive further information regarding use of the Services, please contact us at:

Aligntra Inc.
Wilmington, DE 19808
United States

General inquiries: legal@aligntra.com
Billing disputes: billing@aligntra.com
Data and privacy: privacy@aligntra.com
Technical support: support@aligntra.com