Built for the teams that bring regulated products to market.
Azora was built inside a company that ships a regulated product, and grew around the work that surrounds one: design, quality, manufacturing, clinical evidence, people, and business operations.
Quality records that sit beside the work they govern.
Run ISO 13485-aligned quality workflows beside the engineering and operations records they govern. Keep the source, approval, evidence, and downstream action connected from requirement to release.
- CAPA, NCR, change control, audits, complaints, and post-market records
- Re-authenticated electronic-signature workflows where records require control
- Design controls with requirement, output, verification, and validation links
- MDSAP cycles, gap tracking, vigilance, and regulatory authorizations
- Risk management and FMEA linked to product evidence
Built by a company that ships a regulated product.
We build and certify a regulated hardware product of our own. Azora the platform came out of the spreadsheet graveyard we lived in while doing it. Every feature was sharpened against real production constraints, not a hypothetical SaaS demo.
- Serialized unit tracking with configurable generation columns
- Lab equipment + calibration scheduling
- Production stage management for serialized units
- BOM-to-deployment genealogy
- Vendor risk register integrated with purchasing
Agile for physical products.
Sprints work great for software. Hardware development has long lead times, physical dependencies, and "the part shipped from China" risks. Azora handles both — same Sprint board, but with vendor lead-time bars on the Gantt chart.
- Sprint with story points, burndown, and velocity
- Cross-team Gantt with vendor lead-time overlay
- Bug tracking linked to specific units / serial numbers
- Roadmap that shows physical milestones (DV / PV / pilot run)
- Real automation engine — runs on the same DB as your work
Connect the stack around the product.
You're 12 people. You shouldn't need a Director of Tooling. Azora replaces the handoffs between project tools, quality systems, docs, people, purchasing, and finance with one login, one bill, and one shared operational model.
- One identity across quality, product, operations, and business workflows
- One plan instead of per-module packaging
- Cross-solution reporting and shared record context
- Every commercial solution included — free during open beta
- Self-host or hosted — same code, your call
Nine editions. One database underneath.
Pick the edition that matches your team. Each one scopes the platform to the work you do — and every page below leads with the problem it solves, not the feature list.
Project Management
Sprints, kanban, and portfolio health — with QC gates, serialized units, and vendor lead times built in.
For teams that build and serialize a physical product
Explore →Quality Management
CAPA, audits, risk, and full traceability in one database — ISO 13485 evidence as a query, not a three-week scramble.
For ISO 13485 / FDA-regulated teams
Explore →HR & People
Directory, leave, onboarding, and capacity — in the same database as the projects your people deliver.
For growing teams
Explore →ERP / Operations
Purchasing, inventory, units, and a real general ledger — SAP discipline without the SAP invoice.
For hardware companies
Explore →Engineering & R&D
Design controls, risk, and traceability — generated from the engineering work you're already doing.
For R&D teams that own design controls
Explore →Collaboration
Messaging, wiki, decisions, and support — knowledge that lives one click from the work it's about.
For teams drowning in disconnected tools
Explore →Clinical R&D
Clinical studies plus the full regulated eQMS evidence chain and AI lineage — audit-ready trials without the eClinical price tag. Technology showcase / preview.
For AI-driven trial teams
Explore →Document Control & e-Sign
Controlled documents with review and approval routing, 21 CFR Part 11 electronic signatures, and a retained revision history.
For quality and regulatory teams
Explore →Management OS
Cadence, OKRs, and talent computed from real work — management metrics that aren't self-reported.
For leaders & managers
Explore →Every module, free during open beta.
Explore the live demo now — instant, read-only, no signup. Or request access and we'll provision a tenant with industry seed data within 24 hours. Free while Azora is in open beta.