The EU AI Act paperwork your QA team needs — auto-generated, signing-ready.
Praxara's Compliance Pack generates the EU AI Act (Annex III, Art. 9/11/13), Annex 22 GxP-for-AI, 21 CFR Part 11, and GDPR artefacts pharma QA teams need before enforcement — built from your live AI inventory in days, not months.
Regulatory teams shouldn't choose between speed and evidence.
Generic LLMs give you answers. They don't give you defensible answers. In pharma that's the whole job — every CSR extraction, PSUR section, ICSR coding decision has to survive an MHRA inspector asking "show me how you got there".
Praxara is built the other way around. Every AI output carries its model, version, prompt hash, reviewer identity, and a SHA-256 link to the row before it. When the inspector arrives, you click a button.
Three workflows, one platform — and the same audit trail across all of them.
eCTD Module 1-5 structure, gap analysis, cross-reference QC, readiness dashboards for IND, NDA, MAA, variations.
ICSR intake (manual + E2B inbound), MedDRA coding, ICH E2D safety narratives, E2B(R3) export, PSUR/PBRER drafts.
PSMF review against GVP Module II, SOP structure, 21 CFR Part 11 readiness, gap analysis vs published rule sets.
From folder upload to submission in four deliberate steps.
Drag a folder or ZIP. Each document is auto-classified into one of 60+ pharma document types. eCTD modules inferred from path.
Azure Document Intelligence pulls text + tables + sections. Gemini 3.1 Pro extracts structured data against a validated schema.
Side-by-side PDF + JSON. Reviewer approves, corrects, or rejects with a controlled reason code and e-signature.
Output sealed with 21 CFR Part 11 signature, SHA-256 audit chain entry, ready to export in eCTD or E2B(R3) format.
The rails generic AI can't give you.
Every action hashed SHA-256 to the previous. Verifiable at inspection. Generic AI gives you a chat log.
Password + reason code + timestamp + bound to identity. Meets Section 11.100 prior-agreement requirements.
Data stays in West Europe by default. Full DPA, sub-processor list published. No customer data trains anyone's models.
Required under EU AI Act Annex III. Maintained in-platform, not in a spreadsheet.
Documents nest into the eCTD module tree. Readiness dashboard surfaces gaps before inspectors do.
Work routes to the right person with an SLA. Overdue items escalate. 4-eyes gates available for high-risk steps.
Multi-provider AI routing, your choice of fallbacks.
Primary model: Gemini 3.1 Pro for extraction + coding. Fallbacks: Claude Sonnet 4.5 and GPT-4o. Per-task routing is DB-configurable so you can swap models without a redeploy. Every call costed and audited.
- OCR: Azure Document Intelligence (primary) with pdf-parse fallback
- Embeddings: OpenAI text-embedding-3-small, 1536 dims, pgvector-indexed
- Storage: Azure Blob with AES-256 at rest, TLS 1.2+ in transit
- Queue: Bull + Redis for durable background processing
- Observability: Sentry + Application Insights + structured pino logs
Ready to see Praxara against your own documents?
A 20-minute demo. Bring a redacted CSR, PSMF, or ICSR sample — we'll run it live and show you the audit trail on the way out.