Pharma, medical device, dietary supplements, food. The common thread: the audit record assembles itself as operators work — no parallel paper, no end-of-week reconciliation, no surprises at QA review.
Time to release a batch (paper → V5)
Recurring deviations after CAPA effectiveness
FDA 483 observations on the in-scope process
Audit-pack export, any product, any window
A mid-size injectables manufacturer cut its post-batch reconciliation window from two weeks of paper review to a same-day, two-signature electronic batch release. Deviations now get triaged at the kiosk instead of being discovered at week-three review.
We stopped finding surprises at QA review. The kiosk catches it at step 12 — when we can still fix it.
A Class-II device maker swapped a 40-page paper Device History Record for a live eDHR built as operators worked. Their notified-body surveillance audit closed in three days with zero major findings — the auditor exported records directly via a scoped share link.
The notified body asked for evidence, we sent a link. They saw exactly what we saw. Audit closed.
A supplement contract manufacturer brought MMR approval, training acknowledgement and first WO release into the same week. Two-sig approval on the MMR (preparer + reviewer per 111.205), kiosk gating until every assigned operator acknowledged the new SOP, then a clean release.
We had been waiting six weeks to launch a SKU because the binder kept moving desks. Now it's a Tuesday.
Customer names available under NDA — most regulated buyers prefer it that way until the next renewal.
