
An intelligent collaboration platform for drug R&D and manufacturing quality management
Upgrading from manual line-by-line work to human-AI collaboration with proactive AI delivery
From protocol design to batch release, from data verification to submission preparation
AI-assisted protocol design: validation, process and stability study protocols drafted by AI and reviewed by experts.
View docs →Not a repackaged general-purpose AI tool — built around the full CMC lifecycle and GMP quality systems
Quality knowledge organized as a knowledge graph — 27 knowledge nodes, 238 semantic edges, vector-embedding retrieval augmentation. Every AI answer is grounded and citable, dramatically reducing hallucination on pharmaceutical terminology.
Detection, tracing and compliance agents work in series: automatic CPP deviation detection → graph-based root-cause analysis → CAPA ticket drafting, with the full workflow automated and recorded.
Query platform data in natural language — "What is the purity trend of the last 10 batches?" answered instantly. 22 slash commands cover high-frequency operations; type / to invoke.
SHA-256 hash chains record every critical operation; log integrity is verifiable, meeting GMP data integrity (ALCOA+) and inspection requirements.
Every use deposits reusable quality knowledge assets for your organization
Lab and production data unified and governed into a high-quality AI foundation
Protocols, reports and submissions drafted by AI; humans review and decide
Experts gate critical judgments; e-signature trails keep accountability clear
Output becomes organizational assets; expertise no longer walks out the door
↻ Output becomes organizational assets · Members reuse directly · Enterprise efficiency compounds
From policy to technology — safeguarding enterprise-scale AI adoption in GMP environments
Every output stands up to inspection
Submission-style reports automatically run review rules based on ICH Q8/Q9/Q10/Q11, presented on a red-amber-green risk board.
Deviation, CAPA and change management flows embed GMP requirements; data integrity follows ALCOA+ principles.
Deliverable approvals support e-signatures, aligned with 21 CFR Part 11 concepts.
Every operation has clear boundaries
5 preset roles and 25 fine-grained permissions; role-based access control with permission inheritance.
Responsibilities assigned by organizational structure; permission boundaries are transparent at audit time.
Create, update, delete and approval events all recorded, filterable by resource, user and agent.
Your data always stays under your control
Start fast with a SaaS subscription, or deploy on-premise with data fully inside your environment.
Front-end assets self-hosted with no external CDN dependency — fits intranet and air-gapped environments.
Without your authorization, business data is never used for model training or disclosed to third parties.
See typical scenarios and workflows by role
Multi-agent CAPA flows automatically: detect → trace → draft → verify to closure, with record review and quality knowledge governance in one place.
View scenarios →Real-time monitoring and alerting on critical process parameters; batch-release summaries and analysis reports generated in one click.
View scenarios →Automated data validation; batch summaries, CPP-CQA and stability reports drafted by AI, exported to Word/PDF straight into the approval flow.
View scenarios →eCTD Module 3 trace-through reports with data lineage to source batches, plus ICH pre-checks on a red-amber-green board.
View scenarios →Custom dashboards plus natural-language queries — production and quality status answered instantly.
View scenarios →Book a product demo, or start a free POC