SOPs
SOP & Policy Search
"Which SOPs govern cleaning validation for equipment train B?" Answered with document numbers, versions and effective dates.
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Pharma & Life Sciences
Private AI for Pharma Documentation — Inside Your GxP Environment.
Your quality system holds every answer your team needs and surfaces almost none of them. FortiqAI installs on your own servers and makes SOPs, deviations, CAPAs, validation records and regulatory documentation answerable in plain language — with citations to the exact document and page, and no data leaving your network.
01
The knowledge exists. The retrieval doesn't.
- A deviation investigation stalls because nobody can confirm whether the same root cause appeared in a previous batch.
- A CAPA is raised that duplicates one closed eighteen months ago, because the earlier record is unsearchable.
- An auditor asks for every SOP referencing a specific cleaning agent, and two people spend a day in the DMS.
- A regulatory query needs a cross-reference across three years of stability data, held in PDFs.
- A new QA executive takes six months to become useful, because the institutional knowledge is in documents nobody can navigate.
None of this is a documentation problem. Your documentation is excellent — that's why there's so much of it. It's a retrieval problem.
02
Your quality data cannot leave the site. That is not negotiable.
Batch records, formulation details, deviation histories and unreleased trial data are among the most sensitive assets a pharmaceutical company holds. Uploading them to a public AI service is a confidentiality exposure, a data-residency question, and — for anyone operating under GxP — a validation and audit-trail problem all at once.
FortiqAI removes the question entirely. The system runs on your infrastructure. It works with no internet connection. There is nothing to upload and nothing to explain to a regulator about third-party processing.
03
Where pharma teams get value first.
Deviations
Deviation & CAPA History
"Has this failure mode occurred before, and what was the corrective action?" Surfaces prior records and their closure evidence.
Regulatory
Regulatory Dossier Support
Locate, compare and assemble source content across CTD modules and change histories.
Validation
Validation & Qualification Records
Retrieve IQ/OQ/PQ evidence, protocol deviations and requalification history for a given system.
Pharmacovigilance
Literature Screening
Triage and summarize literature against your product and safety-signal criteria, with every source cited.
Suppliers
Supplier & Vendor Qualification
Cross-check supplier documentation, audit reports and change notifications against your acceptance criteria.
04
Designed to sit inside a validated environment, not beside it.
01
Deployment
Containerised (Docker/Helm) or VM appliance, inside your own datacentre or private cloud. Air-gapped installation supported.
02
Access Control
Role-based access by site, department, product or project. SSO through SAML, LDAP or OIDC.
03
Audit Trail
Every query logged with user, timestamp and documents accessed, exportable for internal audit or inspection readiness.
04
Traceability
Every answer links to the source document, version and page. No unattributed output.
05
Human in the Loop
The system retrieves, compares and drafts. Your people review, approve and sign. It does not release, approve or close anything.
06
Validation Support
We provide installation and configuration documentation to support your CSV process, and work to your qualification protocols. FortiqAI is designed to support your Part 11 and CSV obligations, with documentation to assist qualification — qualification itself is performed by you, in your environment.
05
Built in Gujarat, for the plants and R&D centres around it.
FortiqAI is based in Gandhinagar, in the middle of India's densest pharmaceutical cluster. That matters for a deployment that lives inside your building: our team can be on site, work with your IT and QA groups directly, and support your qualification cycle in person rather than over a ticketing system.
Pharma AI
Book a Pharma Pilot.
A scoped, fixed-price pilot on one workflow — SOP search, deviation history, or whatever your team answers manually today.