Cut audit prep from a month to a day.
Opwise replaces the four to six point tools tier-2 manufacturers stitch together — EQMS, APQP/PPAP, SPC, calibration, connected-worker — with one platform. Audit-ready by default. Self-serve in under an hour.
Illustrative — real control logic, simulated process data.
What's in the platform.
CAPAs, NCRs, change control, multi-signer e-signatures, 21 CFR Part 11 compliant.
Characteristic lists, control plans, PFMEA, PPAP package assembly.
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.
Get on the waitlist.
Pro tier ($99/user/month) opens to early users first. We'll email you when your invite is ready — no marketing drip in between.