One platform. Six fewer vendors.
What a tier-2 manufacturer typically buys from four to six vendors — connected worker, EQMS, APQP/PPAP, SPC, calibration, AI — bundled into one subscription, with one data model, and one audit trail.
Procedures operators actually follow.
Operators run typed procedures on tablets. Conditional jumps so the procedure adapts to what's in front of them, not what the author imagined. In-step measurements feed SPC in real time.
- Typed step model with conditional branches
- Photo capture, signature capture, gauge reads in-step
- Real-time SPC rule evaluation against control limits
- Setup, work-order, shift, or ad-hoc production sessions
- Offline-capable (tablet keeps running if WiFi drops)
Document control without the seven-system shuffle.
One unified document model — procedures and static files share the same draft → approved → active → superseded lifecycle. Multi-signer e-signatures bound to content hash, audit-grade by default.
- CAPAs, NCRs, change control, RMAs, internal audits
- Multi-signer approval workflows (21 CFR Part 11 compliant)
- Content-hash signature binding — re-signing required if content changes
- Tenant glossary for org-specific terminology overrides
- Always-editable comments without breaking audit-trail integrity
Drop the spreadsheets. Keep the engineering rigor.
Characteristic lists, process flows, PFMEAs, and control plans live in one place — linked, versioned, signed. PPAP package assembly pulls from your live data instead of asking someone to chase it down.
- Process flow diagrams with characteristic linking
- PFMEA with severity/occurrence/detection scoring (AIAG-VDA aligned)
- Control plans linked to characteristics and inspection methods
- PPAP level 1–5 package assembly from live tenant data
- ISIR / FAI workflows for AS9100 shops
Real-time rules. Server-computed math.
SPC runs on every step result the moment it lands. Western Electric, Nelson, custom rules. Control limits computed server-side from your actual data — not in a JavaScript chart that any QE can override.
- Real-time rule evaluation on procedure step results
- Western Electric, Nelson, and tenant-defined rules
- Server-computed control limits, capability, Cpk/Ppk
- Charts via polling refresh — no client-side math
- Rule violations route to the inbox of the right role
Native calibration. AIAG MSA-4 done right.
Gauge lifecycle from receipt through retirement. AIAG MSA-4 studies (Gage R&R, bias, linearity, stability) with the math done right. Every measurement event is traceable from gauge → study → step → part.
- Gauge master data, calibration schedules, due-date alerts
- AIAG MSA-4 studies — Gage R&R, bias, linearity, stability
- Full traceability: gauge → measurement event → step result → part
- External system of record supported if you'd rather keep your existing calibration tool
- Calibration certificates with content-hash signatures
AI that drafts the boring 80%.
Specific AI capabilities, not 'AI-enabled' marketing copy. Every agent has a defined input, output, and approval gate. You decide what gets accepted.
- Draft CAPAs from prior similar NCRs and root-cause patterns
- Author procedures from a natural-language description + reference docs
- Assemble audit-prep packages on demand (internal or external)
- Generate validation evidence (URS, FRS, OQ) from CI artifacts
- Conversation-driven self-serve onboarding for new tenants
Audit-grade from the substrate up.
Most QMS platforms bolted regulatory rigor onto a general-purpose CRUD app. We started with the regulatory requirements and built the platform around them. Every architectural decision is in a published ADR.
Each customer's data sits in its own database boundary — not in a shared table with a "which-customer-is-this" column. Cross-tenant access isn't blocked by application code; it's structurally impossible. Auditors and IT reviewers recognize this on the first question.
Every change to every record is logged in a way that's mathematically impossible to alter after the fact. If anyone tried — including an admin, including us — you'd see it. The kind of audit trail 21 CFR Part 11 §11.10(e) actually asks for, not a "log table" with a "deleted" flag.
When you sign a record an AI helped draft, the signature captures which model, which prompt version, and what context the AI used — bound into the audit chain alongside the content. If a regulator asks "how was this CAPA written?" you have the receipts at the artifact level, not "AI was used somewhere."
Procedures and static files (PDFs, drawings, SOPs) share the same controlled-document lifecycle. A static SOP can be converted to an executable procedure under one continuous document identity — same revision history, same audit trail.
Most platforms hand you a static PDF when your IT or QA team asks for software validation. Ours regenerates with every release — requirements, functional spec, and operational qualification all derived from the build itself and signed by the pipeline. GAMP 5 conventions, always current.
Tenant configuration via conversation. Document import via OCR + LLM. Master data via integrations. The platform is designed to stand itself up — no consultant, no months-long implementation.
Ready to see it?
Pro tier opens to early users first. Plant deals are sales-led — Tim handles those personally.