One platform. Six fewer vendors.
What a tier-2 manufacturer typically buys from four to six vendors — connected worker, EQMS, shopfloor inspections, structured audits, 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
- Session state preserved across step navigation and page refreshes
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One unified document model — procedures and static files share the same draft → approved → active → superseded lifecycle.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
One worksheet, not five disconnected documents.
Control plan, PFMEA, inspection plans, and the PPAP submission all live on one APQP worksheet, keyed to the part revision and the AIAG phase you're in. Change a characteristic once, see it everywhere it's controlled — not copy-pasted across four files and approved on three of them.
- Control plan lines linked to drawing characteristics — full GD&T, classification symbols, inline fail-response automation
- PFMEA authored on the same worksheet, scored your way — AIAG-VDA Action Priority or traditional RPN
- One-click SPC enrollment straight from the control plan line
- PPAP submission tracked against every AIAG element — evidence, waivers, resubmission history
- Part Submission Warrant and full PPAP package generate as PDF or zip on demand
For teams that own the design, not just the process.
One design-record core — requirements, outputs, verification & validation, and a linked risk analysis — serves both DFMEA/DVP&R for design-responsible automotive suppliers and DHF for medical device design houses. If your OEM owns the drawing, you don't need this section. If you own the design, it's built the regulated way.
- Requirements → outputs → V&V traceability matrix, scored automatically for coverage gaps — never a silent pass
- DFMEA: mode → cause → control failure chain (AIAG-VDA Action Priority), each control linked to the design artifact that backs it
- Independent-reviewer-enforced design reviews, signed at every stage — planning, inputs, outputs, verification, validation, transfer
- Design transfer hands off to APQP/PPAP or the Medical Device File through a verified, one-way link — no re-entry
- One model, two report skins: DHF for medical, DVP&R + design record for automotive
Data capture that doesn't slow the line down.
Configurable inspection forms operators can run without training — big touch targets, barcode scan-in, guided steps. Results land in the system the moment they're submitted, timestamped and attributed, with no re-entry downstream.
- Configurable inspection forms and checklists — no code required
- Large-format, touch-optimized UI designed for production environments
- Barcode / QR scan-in for part, lot, and work order context
- Results submitted directly to the platform — no batch uploads or manual re-entry
- Every result timestamped, operator-attributed, and immutably logged on submission
From a change idea to a signed ECN — one thread, not an email chain.
Change Idea, ECR, ECO, and ECN follow the vocabulary your buyers already know from PPAP — not generic 'change control.' Batch related ECRs into one ECO, and the impact assessment auto-surfaces every document, control plan characteristic, and open PPAP submission the change touches.
- Change Idea intake traces back to the NCR, CAPA, SCAR, or audit finding that triggered it
- Impact assessment auto-surfaces affected records and auto-generates implementation tasks — zero template setup
- PPAP re-trigger evaluated against AIAG 4th-edition criteria directly on the ECO, evidence kept even when the answer is no
- AI-drafted ECN narrative, content-hash bound on issue — the PPAP element 2 artifact, done
- Deviation and Waiver track time- or quantity-limited exceptions, with recurrence detection nudging toward a permanent fix
Risk register, ISO 14971 hazard analysis, one dashboard.
Organizational risk and product risk are different disciplines with different regulatory bases, so they're different records — not one generic 'risk' table stretched to cover both. Both roll into a single dashboard alongside SPC violations, CAPA, and training gaps.
- Risk register: likelihood × impact auto-computes priority and flags out-of-tolerance items — never hand-set
- ISO 14971 hazard analysis: hazard → situation → harm chain, three-tier control hierarchy, pre- and post-control risk auto-calculated
- Benefit-risk acceptance path when residual risk doesn't meet criteria — documented, not hidden
- Product risk files follow the same signed, revision-controlled lifecycle as every other controlled document
- One dashboard rolls up the risk register, PFMEA, and product risk files by priority alongside SPC, CAPA, audit findings, and training gaps
Structured audits from the floor to the boardroom.
Layered Process Audits (LPA) built in — schedule cadences across operator, supervisor, and management tiers, run them on a tablet in minutes, and track adherence trends before a finding turns into a nonconformance. Internal and supplier audits follow the same structured workflow.
- Layered Process Audits (LPA) with configurable tier cadences
- Audit scheduling with automatic assignment and escalation
- LPA compliance dashboards — spot drift in process adherence by line, shift, or question
- Internal audit workflows linked to CAPAs and corrective actions
- Supplier audit support with external participant access
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 — all eight study types.
Gauge lifecycle from receipt through retirement, gauges that write their own readings straight into the step — no transcription — and MSA studies scored the way AIAG actually defines them, including the customer-specific overrides your OEM hands you.
- Eight study types: GR&R (crossed and nested), bias, linearity, stability, Type 1 Cg/Cgk, and attribute agreement with kappa
- Customer MSA profiles — per-customer thresholds and computation method, down to per-part and per-characteristic overrides
- Two-signature acceptance, with a guard-banding rationale required when a marginal result still gets approved
- Gauges connect directly — Web Bluetooth, Web Serial, or a relay agent for RS-232 gauges and camera stations — values land in the step, not retyped
- Full traceability: gauge → measurement event → step result → part; external calibration system of record supported
CMMS-lite: scheduled, tracked, closed out — no CMMS to buy.
Preventive maintenance for every physical asset — gauges, tooling, and production equipment — with the parts-inventory and labor-costing bloat of a full CMMS left out on purpose.
- Whichever-comes-first triggers: time-based and usage-based, reading piece counts the platform already has — no separate meter system
- PM work orders run as a guided procedure with a full execution trace, not a free-text checklist
- Location history and calibration lifecycle for gauges, tooling, and production equipment in one place
- PM compliance rate and overdue aging computed live — the number your IATF auditor asks for first
- Structured failure codes on corrective work build the maintenance history a future predictive-maintenance model would train on
Qualified or not — no proficiency-scale theater.
Binary qualified / retraining-required / expired is what IATF, AS9100, and FDA QMSR actually require — not a 1-4 proficiency scale nobody keeps current. Procedure-linked skills connect document control to training automatically.
- Skills link to a specific procedure, a process capability, or an external credential — job titles carry the required list
- Activating a new procedure revision auto-flags every qualified operator for retraining, with a configurable grace period
- Gap view: who's missing what, by person, by skill, or by job title — computed live, not a stale spreadsheet
- Effectiveness evidence captured per skill — observation, execution, written test, or manager sign-off — not just a completion checkbox
- Full qualify / retrain / expire audit trail: who certified whom, when, and on what evidence
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 guided 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.
Your quality system shouldn't hold you back.
The manufacturers who outperform don't have more people — they have better systems. Opwise brings AI-powered quality management to the teams who've been underserved by legacy vendors for too long. Take the next step.