Pharma & biotech
Months of medical writing for a single module, deviations piling up unclosed and a weekly literature screen that waits for nobody. Inferana puts open models over that documentation, inside your perimeter, with every query logged.
What each regulation in your sector requires, and which part of that the deployment solves.
Validation, change control, access management and audit trail for computerised systems.
A dedicated deployment with a pinned model version, access control and a record of every interaction, the basis your team validates on.
Complete and attributable electronic records, with audit trails and access controls.
Every query is logged with user, team and timestamp, exportable into your document management system.
Protection of subject data and traceability of trial documentation.
Trial data is processed inside your perimeter, with prompts never stored or used to train models.
Minimization and confidentiality of health data, with control over international transfers.
Inference in the EU or on your own infrastructure, with prompts and responses never stored.
The same ones you already use, specific to your sector.
The material exists, spread across reports, SOP versions and email threads, and every time someone has to pull it together the same things come back:
We have been drafting Module 2 for months and the filing date has not moved.
Medical writingDeviations pile up and the investigation gets written the week before the audit.
Quality assuranceThe weekly literature screen eats up the whole of Monday.
PharmacovigilanceHalf an hour to find which SOP version was in force that day.
ManufacturingIf I cannot reproduce the answer, I cannot defend it to an inspector.
GxP systemsThe molecule sequence cannot end up on someone else's server.
R&DA dossier draft ended up in a tool we have not approved.
Regulatory affairsNo, and be wary of any vendor who claims otherwise. A computerised system is validated in the environment where it is used, with your procedures and your intended use, so the validation is yours. What we provide is what makes it possible: a dedicated deployment with a pinned model version, access control, a record of every interaction and the deployment documentation for your validation plan.
With the model version pinned in your deployment and the logged interaction: same model, same parameters, same input. A public endpoint that updates the model underneath you makes that reproducibility impossible. You decide when the version moves, and it goes through your change control.
Electronic signatures and record approval live in your eQMS or document management system. We provide an attributable record of every query, with user, team and timestamp, exportable to file with the record. Custody of the regulated record remains with the company.
Prompts and responses are never stored or used to train models, and with an on-premise deployment the data never leaves your infrastructure. Legal basis, informed consent and prior pseudonymization remain the sponsor's responsibility. Upfront anonymization reduces what reaches the model at all.
The answer cites the document, its version and the section, and the reviewer opens the SOP to check it. The index is built from whatever your document management system publishes, so you set what counts as current. A withdrawn document stops being indexed, and a stale index answers with stale content.
Yes, with the same key. There the query does go out to the model provider, so that mode is kept for public literature. Trial data and molecule information are handled with the open models inside your perimeter. It is configured per team.
You can audit us as a supplier, and with an on-premise deployment you audit your own infrastructure with the procedures you already run. For managed European infrastructure we hand over the deployment and service documentation. Scope and notice periods are set in the contract.
No. The API is OpenAI-compatible: swap the key and the endpoint and the code stays as it is. If the affected system is GxP, that change enters your change control and your qualification, which is your work no matter how compatible the API is.
In the demo we go through your case: which models you need, where they run and what it takes to meet the regulation that applies to you.
We reply within one business day.
