Igazent QMS is a full suite cloud eQMS for small and midsize manufacturers. CAPA, Audits, Document Control, Training, Calibration, Approved Supplier List, and more live in one system, with 21 CFR Part 11 electronic signatures and an immutable audit trail to help you stay audit-ready.
People: Your greatest strength: trained, trusted, and proud of the work.
Process: How good work becomes repeatable, every shift and every lot.
Product: The proof of all of it, in your customer's hands.
01 · RecordSignatures, state changes, and edits are enforced and logged by the database itself. Signed means frozen.
02 · SetupTemplates for every module, with company settings for the fields, lists, and numbering you want to change.
03 · AIDraft procedures and work instructions from a short interview, written in your company's own house style.
04 · FitDense, fast screens for a smaller quality team, not an enterprise rollout with a consultant attached.
Built to the 2026 text, which asks that records be protected from alteration and deletion. That's how Igazent works already.
Clauses 4–10Approved supplier parts with first article due flags, out-of-tolerance cases, and customer property loss notices.
Rev DComplaints, change control, calibration, and training records with 21 CFR Part 11 electronic signatures, for device makers and contract manufacturers.
Clauses 4–8In a quality system, the truth is the product.
A nonconformance, a calibration, a training sign-off, or a document revision is only worth something if you can show who did it, and when. Igazent QMS is built around that basic philosophy.
The rings are Borromean: woven so that no two are linked on their own, yet the three hold together. Cut any one and the other two fall free. A quality system works the same way. Good people with a weak process, or a sound process nobody follows, doesn't produce good product.
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