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Draft. This policy describes how the product works today and has not yet been reviewed by counsel. It is not legal advice. Email us if anything here matters to a decision you are making.

Last updated 12 October 2026

Privacy

We would rather under-claim than over-claim. Everything below describes what the software does today, not what we intend to build. Where a capability does not exist yet, this page says so.

This page collects nothing

The marketing site you are reading now has no analytics, no tracking pixels, and sets no cookies. There is no consent banner because there is nothing to consent to.

Its two forms are the free classification lookup and the free predicate search. What you type is sent to FDA's openFDA database to find matching records and is not saved by us. Your IP address is held in memory for up to an hour, only to limit how many searches one visitor can make.

One disclosure: the fonts on this site and in the app are served by Google Fonts, so loading a page sends your IP address, browser user-agent, and referring page to Google. We plan to self-host the fonts and remove that dependency.

The application

Everything in this section applies once you sign in at the app.

What we store about you

  • Your email address, display name, and an argon2id hash of your password. We never store the password itself.
  • Your role in each workspace you belong to (viewer, reviewer, editor, or owner), and an optional job title and experience level you can fill in on your profile.
  • The email address of anyone you invite to a workspace, so the invitation can be matched to them when they accept it.
  • Records of emails we attempted to send you (recipient, subject, delivery status) so failures can be diagnosed.
  • Comments you write in a workspace, with who you mention and who a comment is assigned to. They stay with that workspace's records and are visible to its members.
  • If a workspace owner asks one of our platform experts to sign off a record and the expert accepts, that expert can read the workspace like a reviewer (without exporting it or reading its audit trail) until a week after the due date, and their access ends when they sign off. The owner confirms this before the request is sent.
  • Your personal library: templates, SOPs and snippets you save to it. They belong to your account, not to any workspace, and only you can see them. Saving something from a client's workspace asks you to confirm it holds none of their confidential details, and is recorded in that workspace's audit trail.

Cookies

One cookie, rc_session, set when you sign in. It holds a random token; only a SHA-256 hash of that token is stored on our side, so the database cannot be used to impersonate you. It is HttpOnly (unreadable by JavaScript), SameSite=Lax, and marked Secure in production. It lasts 14 days and renews while you are active. Signing out deletes it; changing your password ends every other session.

This cookie is strictly necessary to keep you signed in. We set no advertising, analytics, or third-party cookies anywhere in the product.

IP addresses and audit records

A regulated quality system has to record who did what. We store the IP address and browser user-agent against your sign-in sessions and password-reset requests, and the IP address against entries in the audit trail. If a workspace owner shares a device with you through a read-only link, opening the page and each download are recorded in that workspace's audit trail with your IP address; no account or other detail about you is involved. Audit entries also record the action, the affected record, and before/after snapshots of what changed.

The audit trail is append-only and enforced as such by the database itself, so it cannot be edited or deleted, by us or by you. That is the point of it, and it has consequences for deletion (below).

Your content

Device profiles, requirements, risks, tests, documents, and uploaded files belong to you. Uploads are stored on an encrypted volume in the United States and are addressed by a hash of their contents rather than by filename. We do not scan uploaded files for malware, and we do not send their contents to any third party.

Usage data

Inside the app (not on this website) we record which features are used, so we can tell what helps and whether people come back. Each record holds: the feature (for example “opened the traceability matrix”), when, which workspace, and a random ID that stands in for you. It does not hold your name, email, IP address, anything you typed, or which record or document you were looking at. It is recorded by our server, so there is no tracking script or cookie in your browser, and it stays in our own database: no analytics company sees it. It is deleted after 13 months.

Who else processes your data

  • Railway handles hosting, the database, and file storage. Infrastructure is in the United States (US-West).
  • Anthropic powers the AI features. This one deserves plain language: when you use drafting, predicate analysis, or ask a question, we send the relevant device details and excerpts of your own records and documents to Anthropic's Claude API. We do not send your name, email, or account identifiers. But we also do not strip names out of document text you have written, so if you typed a person's name into a document, an excerpt containing it may be sent. Every AI call is logged in your workspace so you can see exactly what was sent.
  • Resend will deliver transactional email only, workspace invitations and password resets, once email is switched on. It is not on yet, so no email is sent to anyone: an invitation is a link the app shows you to copy and send yourself, and password-reset emails are not sent either. No marketing email is sent, and there is no mailing list.
  • Slack or Microsoft Teams, only if a workspace owner connects a channel. Each post is the one-line title of a workspace update (for example “CAPA-003 is past its due date”) and a link back; never a record’s contents, a comment or a document, and nothing addressed to one person.
  • Atlassian (Jira), only if a workspace owner connects Jira. When someone creates an issue from a record, Jira receives its number, title and a link back, and its contents only if the owner turned that on; we read back each linked issue’s status.
  • Google Drive, only when you import a file from it. You pick the file in Google’s own window; Google gives your browser permission for that one file, we fetch it once to import it, and we don’t keep the permission. We send Google nothing about your records.
  • openFDA and FDA handle predicate and clearance lookups, eCFR (the Office of the Federal Register) answers regulation lookups, and NCBI PubMed answers literature searches. Only search terms such as a product code, K-number, regulation number, device description or search phrase are sent. No account or workspace information leaves with them.

Your identity provider, if your workspace uses single sign-on. When you sign in through your company's provider, it tells us your email address, your name and an identifier for you; we use them to sign you in and to add you to that workspace. We send the provider nothing about your records.

AI clients you connect yourself. If you add the read-only connector to Claude or another AI client with your own API token, that client reads what you ask it to, and its provider handles that data under your agreement with them, not ours. We record each read as ordinary use of your account. Revoking the token stops it at once.

We do not sell your data, we do not share it for advertising, and we take no payment information. Nothing is charged today, so there is no payment processor.

Keeping workspaces separate

Every record carries a workspace identifier, queries are scoped to the workspace you are working in, and PostgreSQL row-level security enforces the boundary underneath the application as a backstop. The database role the application uses cannot bypass it. This matters most for consultants: one client's data is not visible while you are working in another's.

Security

Passwords are hashed with argon2id and must be at least 10 characters. Sign-in and password-reset attempts are rate-limited. State-changing requests carry a CSRF guard. Access within a workspace is governed by roles, and people who are not members of a workspace cannot confirm it exists. Traffic is served over HTTPS.

No system is perfectly secure, and this one is young. We would rather you knew that than read a paragraph of reassurance.

Retention and deletion: what is true today

We keep your data for as long as your account exists. A workspace owner can download the whole workspace as one export at any time. There is no self-service delete yet. Email us and we will delete your workspace and its contents by hand.

Two honest caveats. The audit trail is append-only at the database level, so entries recording who took an action are retained for records integrity even after the underlying record is removed. That is a deliberate property of a quality system, not an oversight. And there is currently no scheduled job that purges expired sessions or old logs; that cleanup happens manually.

If you are subject to GDPR, CCPA, or similar and need something we cannot yet do automatically, write to us and we will handle it manually.

Things this product does not do

Stated explicitly, because quality-system vendors routinely imply otherwise:

  • Electronic signatures are recorded as append-only, tamper-evident sign-off records. They are not a complete 21 CFR Part 11 implementation. Signing asks you to re-enter your password.
  • Uploaded files are not virus-scanned.
  • The software is not validated on your behalf, and we do not supply IQ/OQ/PQ documentation.
  • AI output is a draft. Nothing AI-generated counts as evidence until a human reviews and verifies it.

Changes

If this policy changes materially, we will update the date at the top and tell account holders in the app (and by email, once email is switched on).

Contact

Questions, deletion requests, or anything else: [email protected].

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