Turn any SOP into audit-ready training in minutes.
Every revision triggers retraining. Every interval triggers re-qualification. Bion generates the training, assigns it, collects 21 CFR Part 11 signatures, and keeps your audit trail inspection-ready. Automatically.
How It Works
Everything you need. Nothing you don't.
Bion turns your controlled documents into training, then keeps every employee qualified as those documents change.
Zero manual training creation
Upload an SOP, policy, or work instruction. Bion's AI builds a complete training automatically: learning content, summary, and an assessment with six question types, including AI-graded short answer and ordered steps. No instructional design experience needed.
Retraining that runs itself
When an SOP is revised, everyone who completed the old version is reassigned automatically. Interval-based re-qualification runs on schedule. The weekly retraining treadmill disappears.
21 CFR Part 11 electronic signatures
Trainees re-authenticate at the moment of completion and sign with name, timestamp, and the meaning of the signature. Every record is tamper-evident and backed by an immutable audit trail.
Role-based training matrix
Map required trainings to groups and roles, with one-time or recurring requirements. See qualification status across your organization and answer who is overdue on which SOP in seconds, not spreadsheets.
Syncs with Veeva Vault and SharePoint
Your controlled documents stay where they are. Bion syncs from Veeva Vault or SharePoint, detects new revisions automatically, and keeps trainings tied to the exact document version they came from.
Compliance-grade version control
Every document version and every training version is tracked and archived. Show an inspector exactly which version each employee trained on, with the evidence to prove it, years later.
About Biolumi
Built by people who lived the problem.
In life sciences, training is not optional. Every SOP revision means retraining. Every role has qualification requirements. Managing it for a 100-person site consumes up to half a QA specialist's time, spent on work software should handle in minutes.
Biolumi was founded to fix that. We build AI tools that eliminate the manual busywork of GxP compliance, so quality teams can stay inspection-ready without drowning in paperwork. Bion is our first product.
The team
Alex Yue
Co-founder & CEO
Alex built his career in one of the most quality-critical areas of life sciences, working in the systems that help biologics, vaccines, cell and gene therapies, and sterile injectables meet demanding regulatory standards. As a BSI-certified QMS Lead Auditor, he has seen compliance from both the operational and audit side. That experience shaped his view that compliance training needed to do more than deliver content. It needed to generate the audit-ready evidence and traceability regulators actually expect. With an MBA, executive education at INSEAD, and experience across complex global organizations, Alex brings the commercial leadership and international perspective needed to scale Bion in markets where compliance pressure is greatest.
LinkedIn
Damian Hirsch
Co-founder & CTO
Damian built his career at the intersection of deep technical research, applied AI, and real-world deployment in highly demanding industries. He holds a PhD in Aerospace Engineering from Caltech and completed graduate studies in Mechanical Engineering at ETH Zurich. He has since focused on AI strategy and product development in industries where precision, reliability, and trust are essential. He designed the core engine behind Bion, which turns unstructured policy documents into complete, audit-ready training programs in seconds. Damian brings the rare ability to translate advanced technical systems into scalable product infrastructure for regulated environments.
LinkedInSee Bion in action.
Request a demo and we'll show you how Bion takes retraining and qualification tracking off your quality team's plate, starting with your own SOPs.