Meet Mira. Batch records, deviations, CAPAs. Mira reads every page against your SOPs before release, and shows her work.
38 batch records reviewed this week, page by page. 6 missing countersignatures, 2 hold-time excursions flagged, 1 CAPA caught closing without evidence. Every finding cited to the page and the SOP clause. 4 deviation drafts waiting for classification.
What Mira does, item by item.
The whole queue, not a sample. Every finding cited back to its source.
Reads batch and production records page by page against your SOPs.
Flags missing signatures, out-of-range entries, and skipped steps.
Drafts deviation summaries with the impacted lots identified.
Tracks CAPA closure evidence so nothing closes on a promise.
Checks supplier certificates against your specs before material moves.
Builds the audit-ready record trail as a by-product, not a project.
- ·Release decisions
- ·Deviation classification
- ·The regulator conversation
- →Record review against SOPs
- →Deviation drafting
- →CAPA evidence tracking
Mira never releases a batch. She reviews and drafts; your qualified person decides, and the decision is logged with the record.
How it earns trust.
Pilot on your history, supervised on your queue, governed always.
Runs on a historical corpus your team already reviewed. You score its findings against what your reviewers caught. No production access.
Works the live queue. Every finding is a draft until a named human approves it, and every rejection is logged and measured.
The envelope never relaxes. Reading, checking, and drafting get automated. Approval stays human, by design.
The hand-off.
How Mira pings a human when it's your call.
The honest answers.
No dodging, no contact-sales-to-find-out.
Is Mira available now?+
Does she make release decisions?+
Can she run inside our network?+
Put Mira on the queue.
Start with a paid pilot on your historical corpus, finished in weeks. Then a full deployment over 3 to 4 months, with a forward-deployed team working alongside your people.
