Qualmitta is used by regulatory affairs, quality, and R&D teams working on confidential device and drug programs. This page describes how we handle your data, where it lives, what the AI models see, and what rights you have.
Every call to Claude Sonnet 4.5 runs under Anthropic's zero-retention API terms. Your prompts, drafts, and outputs are not stored on the model provider's side after the call completes. Nothing you write is used to train third-party foundation models.
Qualmitta's in-house model, Chuck, is trained on expert-graded regulatory content — never on your raw submissions. Training is off by default for individual accounts, and Enterprise tenants are excluded from training pipelines unless a program owner explicitly opts in.
Every project, draft, predicate set, risk item, chat session, and telemetry event is scoped to its owner's user_id at the row level. Team invites grant access explicitly. There is no shared 'global' tenant table.
Application data (projects, drafts, chats, team assignments) is stored in a US-hosted MongoDB cluster managed by the Emergent platform. External calls to openFDA, USPTO ODP, ClinicalTrials.gov and eCFR are read-only and stateless — Qualmitta never sends your device or therapeutic data to those services.
API keys (Anthropic, Stripe, Resend, USPTO) live only in encrypted server environment variables. They are never exposed to the browser, never logged, and are rotated on a defined schedule.
Documents have version history and redlines. Predicate sets, risk items, and QMS SOPs are timestamped on create + update. Admins can pull the export log on request as part of an Enterprise agreement.
We label every AI-powered feature by exactly which model call is triggered, what data leaves your tenant, and where the result lands.
Under GDPR, CCPA, and our own principles — you are always in control of the data you put into Qualmitta.
Email hello@qualmitta.com and we return every artifact tied to your user_id within 5 business days.
Deletion of your account and every associated project, draft, chat and telemetry event is honored within 30 days.
Every artifact is exportable to PDF, DOCX, Markdown, or CSV directly from the workspace.
Contact us to correct any account metadata (name, email, org).
We share our current DPA, subprocessor list, and vendor security questionnaire on request. Reach out and we'll turn it around within one business day.