Terms of Service
Last updated September 22, 2026
These Terms govern use of the Helian website and the Helian platform. You accept them by checking the agreement box when you sign in. Helian records the version you accepted and the time you accepted it. There is no separate public signup form. An administrator creates the account, and you accept these Terms and the Privacy Policy the first time you sign in. If you accept these Terms on behalf of an organization, you confirm you have authority to bind it, and “you” includes that organization.
If your organization signs a Master Subscription Agreement with Helian, that agreement controls where it conflicts with these Terms. Enterprise customers often negotiate additional terms in that agreement.
Who may use Helian
You must be at least 18 years old. You must be using Helian for a business, or on behalf of a business that authorized you to do so.
The service
Helian is an electronic quality management system (eQMS): software your team uses to run and document its quality processes. Your organization remains responsible for its quality management system, including its procedures, decisions, and regulatory obligations. Helian is not a certification body, notified body, or regulator, and using Helian does not by itself make your quality system compliant.
Fees
Fees, if any, are set in an order form or a Master Subscription Agreement. These Terms do not set a self-serve price.
Accounts
Provide accurate account information and keep credentials confidential. You are responsible for activity under your account. Multi-factor authentication is required. Helian may suspend or close an account that breaks these Terms, threatens the service, or must be closed to meet a legal duty.
Acceptable use
You will not:
- Interfere with the service or attempt to access another organization's data.
- Upload malware or use the service to break the law.
- Enter protected health information. Helian does not offer a Business Associate Agreement.
Your records and our software
You own the records and other content you submit. You grant Helian a limited license to host, process, and display that content only to provide the service. Helian owns the software, the site, and the Helian name and marks.
If you send Helian a suggestion about the product, Helian may use that suggestion to improve the service, without any duty to pay you or to keep the suggestion confidential. That license does not cover the quality records in your account.
Confidentiality
Each party will protect the other party's non-public information and use it only to perform under these Terms. This duty does not cover information that is public through no fault of the receiving party, or that the receiving party already knew without a duty to keep it confidential. The duty continues after the Terms end.
Compliance is your responsibility
You are solely responsible for regulatory compliance. That includes FDA QMSR, 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, EU MDR, and related requirements. You are responsible for the accuracy of the records you enter, for the quality decisions you make, and for any submission or filing. Complaint decisions, including reportability, are yours.
Helian provides audit trails, electronic signatures, access controls, and related features designed to support 21 CFR Part 11 and similar requirements. You are responsible for validating Helian for your intended use, configuring it appropriately, and confirming that it meets your requirements. Helian does not guarantee that your use of the service will satisfy any law, regulation, or standard, and does not guarantee uninterrupted operation or error-free output.
AI features
Helian does not use customer content to train its models. AI features, including Haley, produce drafts and suggestions. A person must review AI output before it is used in a quality record. AI output is not regulatory, legal, or quality advice. To the extent permitted by law, Helian is not liable for a decision made from AI output.
No warranty
To the extent permitted by law, the website and platform are provided “as is” and “as available.” Helian disclaims warranties of merchantability, fitness for a particular purpose, and non-infringement. Helian disclaims any warranty that the service will be uninterrupted, error-free, or sufficient to satisfy a law, regulation, or standard.
Limitation of liability
To the extent permitted by law, Helian is not liable for indirect, incidental, special, consequential, or punitive damages, or for regulatory fines, recalls, lost profits, lost data, or decisions made from AI output, even if Helian has been told those damages are possible.
To the extent permitted by law, Helian's total liability for direct damages arising out of the service is limited to the greater of the fees you paid Helian for the service during the twelve months before the claim, or one hundred U.S. dollars.
These Terms do not limit liability for fraud or willful misconduct, or any liability that applicable law does not allow a contract to limit.
Indemnity
You will defend Helian and its officers and employees against a claim, and pay the resulting damages and reasonable attorneys' fees, to the extent the claim arises from your content, your regulatory use of the service, your breach of these Terms, or patient or health information entered in violation of these Terms.
Termination
You may stop using the service at any time. Helian may suspend or end access if you materially breach these Terms. If Helian discontinues the service, Helian will give you at least 60 days' notice by email.
Your records after termination. For 30 days after your access ends, Helian will provide an export of your records, files, and audit trails on request, in a standard format such as PDF, CSV, or the original files, and Helian will keep them available for that purpose. After that period, Helian will delete your content from the active service. Copies in backups are deleted as those backups expire on their normal schedule. If Helian ends your access for a reason other than your breach, Helian will help you export your records during the export period.
You are responsible for exporting and retaining any records your regulatory obligations require you to keep. Helian is not responsible for keeping your records after the export period ends.
The sections on ownership, compliance responsibility, disclaimers, liability, indemnity, and governing law continue to apply after termination.
Governing law
Helian Inc. is incorporated in North Carolina. These Terms are governed by the laws of the State of North Carolina, excluding conflict-of-law rules. The state and federal courts located in North Carolina have exclusive jurisdiction over disputes arising out of these Terms, except that Helian may seek injunctive relief to protect the service.
Changes
Helian may update these Terms by posting a new version on this page and changing the date at the top. For a material change, Helian will email the address on the account at least 30 days before the change takes effect, unless a change is required sooner by law or to protect the security of the service. The new version applies after that date. The next time you sign in after a new version takes effect, you accept it by checking the agreement box, and Helian records that version and the time.
Other terms
These Terms, the Privacy Policy, and any order form, Master Subscription Agreement, or Data Processing Agreement are the entire agreement about the service. They replace earlier discussions about the same subject. If a court holds one part unenforceable, the rest stays in effect.
You may not assign these Terms without Helian's consent. Helian may assign them to a successor of the business. Neither party is liable for a delay caused by an event outside its reasonable control.
Notices to Helian go to support@helian.ai. Helian may send notices to the email address on the account.
Questions: support@helian.ai