Verixa
Verixa provides a governed-AI workflow platform for regulated life sciences, connecting GxP document authoring and control, training and qualification, and supplier management with bounded AI assistance. The platform keeps human decisions explicit and connected to source context, AI proposals, and audit trails, serving biotech and pharma sponsors, CROs, and eligible GMP manufacturers.
- Regulatory & Compliance Technology
- Artificial Intelligence
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
Regulated life-science organizations such as biotech and pharma sponsors, CROs, and GMP manufacturers must maintain rigorous audit trails for GxP documents, training, and supplier decisions. Disconnected records, fragmented workflows, and the uncontrolled use of AI outside governed processes make it difficult to demonstrate compliance and reconstruct the evidence behind quality decisions.
Solution
Verixa is a governed-AI workflow platform that links GxP document authoring and control, training and qualification, and supplier qualification and management with bounded AI assistance and explicit human decisions. The platform captures which source and version informed the work, who was responsible, what AI proposed, and what a qualified person decided, preserving a complete audit trail. MIRA, the built-in AI assistant, helps organize source material or prepare drafts for review only within approved use cases, and all AI-assisted output remains a proposal until a qualified human reviews, accepts, changes, or returns it. Workflows are scoped and connected through recorded handoffs, ensuring that a completed action in one process does not silently approve another. The platform supports controlled authoring, review cycles, training-impact rules, and effective-use transitions, with prior versions retained as history.
Target Audience
Primary customers are biotech and pharma sponsors, CROs, and eligible GMP manufacturers (including CDMOs) that need governed, audit-ready workflows for GxP document control, training and qualification, and supplier management.
Features
- Bounded AI assistance (MIRA) that organizes source material and drafts content for review, with AI output remaining a proposal until human approval
- Complete audit trail capturing source versions, responsible personnel, AI suggestions, and qualified human decisions for each workflow step
- Controlled-content foundation for GxP authoring and review, including metadata, review routes, approval routes, effective-use rules, and retention requirements
- Training-impact decision rules that create or verify mandatory training assignments when content changes, distinct from completion or qualification
- Five bounded workflows (deviation investigation, RCA, CAPA, document control, inspection readiness) with governed handoffs between them
- SHA-256 audit trail and support for regulatory frameworks including 21 CFR Part 211, EU GMP Annex 11, 21 CFR Part 11, and Annex 22 (Draft 2025)