Stop prepping for audits. Start passing them.
Opwise replaces the four to six point tools tier-2 manufacturers stitch together — EQMS, shopfloor inspections, structured audits, SPC, calibration, connected-worker — with one platform. Audit-ready by default and built to get your team moving fast.
Real product — controlled documents with full revision history.
What we do.
CAPAs, NCRs, change control, multi-signer e-signatures, 21 CFR Part 11 compliant.
Touch-optimized forms and barcode scan-in — data entry that doesn't slow the line down.
Layered Process Audits (LPA), internal audits, and supplier audits — scheduled, tracked, and trending before a gap becomes a finding.
Real-time rule evaluation on production data — Western Electric, Nelson, custom.
Native gauge lifecycle, AIAG MSA-4 studies, full measurement traceability.
Operators on tablets run typed procedures with conditional jumps and in-step checks.
Draft CAPAs from prior NCRs, assemble audit prep, generate validation packages from CI artifacts.
30+ employees. $20M+ revenue. Regulated.
IATF 16949 tier-1 and tier-2 suppliers — stamping, machining, injection molding, assembly.
AS9100D shops with FAI requirements, traceability obligations, and audit cycles you can't fail.
21 CFR Part 11, ISO 13485 — multi-signer e-signatures with content-hash binding, GAMP 5 CSV pathway.
The next evolution of quality management starts here.
AI-powered, audit-ready, and built for the regulated manufacturer who's tired of stitching together a quality stack from tools that were never designed to work together. One platform. One source of truth. One team that's always inspection-ready.