Terms of service
1. What Keelsure and Draft are
Keelsure is a documentation workspace for US seafood importers. It holds the written verification procedures, product specifications, affirmative-step evidence and verification records an importer keeps under 21 CFR 123.12, and produces them in a form an investigator can review. Draft is a free workspace for foreign processors to write and maintain a HACCP plan and share it with the importers they choose. Both are provided by Keelsure (“we”, “us”).
Keelsure and Draft are documentation tools. They are not a certification, an audit, an inspection, a laboratory, or a regulatory filing, and using them is not a substitute for any of those.
2. AI-assisted review
Parts of the service use a large language model to read a HACCP plan against the FDA Fish and Fishery Products Hazards and Controls Guidance (the “Guide”) and to draft hazard analyses and product specifications. You agree to the following about that output:
- It consists of candidate findings for review. It is not a hazard analysis, a HACCP plan, a verification, or a determination of anything.
- It can be wrong, incomplete, or out of date, including in ways that are not obvious. Every finding carries the Guide chapter and table it rests on and, where available, the Guide text and a link to FDA’s page, so that a person can check it. Where the service cannot cite the Guide it reports that it could not determine, and you should treat that as no finding at all.
- The Guide edition and the model used are recorded on every output. A finding is only meaningful against the edition it names.
- Under 21 CFR 123.10, hazard analysis, plan development and record review must be performed by an individual trained in an FDA-recognized curriculum or with equivalent job experience. We are not that individual and the service is not that individual. You will name your trained individual in the service, and no plan review counts toward readiness or appears in an exported binder until that person has attested it. Our support staff do not make hazard or compliance determinations and will redirect any such question to your trained individual.
3. No compliance warranty
We do not represent, warrant, or guarantee that use of the service will result in compliance with 21 CFR Part 123, the Foreign Supplier Verification Programs rule, or any other law, regulation, guidance, standard, or customer requirement; that any product, plan, supplier, or file is or will be compliant, adequate, acceptable, or free of observations; or that any regulator will reach any particular conclusion. The service reports what is on file and what is missing against a stated edition of the Guide. It never states that anyone is compliant, and nothing we say in marketing, support, or documentation should be read as doing so. FDA does not approve, certify, or endorse software, and we make no claim that it has.
Nothing in the service is legal advice. Decisions about how to respond to a Form 483, a warning letter, an import alert, or any other regulatory action are yours and your counsel’s.
4. Records and electronic signatures
The service keeps verification records with controls modeled on 21 CFR Part 11 and on 21 CFR 123.9(f): unique user accounts, server-set timestamps, the meaning of each signature stored with the entry, and an append-only, hash-chained verification log that cannot be edited or backdated. We describe this as Part 11-aligned. We do not certify Part 11 compliance and no third party has. Whether the records satisfy a regulator’s expectation in a given inspection is a judgment we do not make.
5. Your responsibilities
- You are responsible for the accuracy and completeness of what you upload, for having the right to upload it, and for maintaining the records the regulation requires whether or not the service holds a copy.
- You will name a trained individual, keep that designation current, and ensure that person actually performs the review the regulation assigns to them.
- You will not rely on the service as the sole basis for any product-safety decision, regulatory response, or representation to a customer or regulator.
- You will keep your account credentials confidential and are responsible for activity under your account.
6. Supplier data
A processor’s plan and records belong to the processor. A processor using Draft is invited by one importer, and uploading a plan or record through that invitation is what shares it with that importer. We do not share one importer’s data with another, and we do not share a processor’s documents with any importer that did not invite them. See the privacy policy for what we collect and how it is used.
7. Fees and term
Draft is free for processors. Keelsure is provided to importers under the fees, term and renewal set out in your order form. Where an order form says month to month, either party may end it at the end of any monthly period. On termination you may export your file for thirty days, after which we delete it except where we must retain it by law or to enforce these terms.
8. Limitation of liability
Cap. To the fullest extent permitted by law, our total liability arising out of or relating to the service or these terms, under any theory, will not exceed the fees you paid us for the service in the twelve months immediately before the event giving rise to the claim. For a free service, that amount is zero.
Exclusion of consequential damages. To the fullest extent permitted by law, we will not be liable for any indirect, incidental, special, consequential or punitive damages, or for lost profits, lost revenue, refused or detained shipments, demurrage, recall costs, regulatory penalties, or loss of business, however caused and even if advised of the possibility. This exclusion is an independent, severable provision: it stands on its own and remains in force even if any limited remedy in these terms is found to have failed of its essential purpose.
What the cap does not cover. Nothing in these terms limits liability for fraud, for willful misconduct, or for anything that cannot be limited under applicable law. Some jurisdictions do not permit limits on liability for gross negligence or for certain injuries; where that is the case, the limit applies to the extent permitted.
9. Disclaimer of other warranties
Except as expressly stated in an order form, the service is provided “as is” and we disclaim all other warranties, express or implied, including merchantability, fitness for a particular purpose, and non-infringement.
10. General
These terms, together with your order form and the privacy policy, are the whole agreement between us about the service. They are governed by the law and courts named in your order form; until an order form exists, by the laws of the State of Delaware, without regard to conflict-of-laws rules. If any provision is unenforceable, the rest remain in effect. There are no third-party beneficiaries. We may update these terms; material changes will be sent to your account email at least thirty days before they take effect.