// PHARMACEUTICAL MANUFACTURING
Built for the operations that get inspected.
Aurantium started in pharmaceutical manufacturing. Electronic signatures, batch records, lot genealogy, and a complete audit trail aren't features bolted on for a checklist, they're the spine the system was built on, for operations that answer to an auditor.
The challenge.
Pharmaceutical manufacturers are asked to move fast and prove everything. Legacy ERP forces a trade: either a generic system with lots and batches bolted on, or years of consulting to make it fit. Meanwhile the real work, signed formulas, controlled changes, quality status, and traceability that holds up in an inspection, ends up scattered across bolt-ons, spreadsheets, and paper.
// HOW AURANTIUM FITS
Compliance wired through every transaction.
The controls an FDA-regulated operation depends on are native to the data model, not a module you bolt on after go-live.
21 CFR Part 11 signatures
Formula signing enforces employee-number and password re-entry, blocks out-of-order signing, and activates a formula only when every required signature is present.
Batch records from live data
Batch-record templates configurable per formula and printed from live job data, so the master record reflects the actual job, not a retyped copy.
Immutable audit trail
Field-by-field history of who changed what and when, across lots, formulas, postings, and quality status, append-only by design.
Formula versioning & approval
Formulas carry revision numbers, validity dates, and approval status; promoting a new version deactivates the prior one, with record locking during edits.
Quality lifecycle
Available, hold, quarantine, conditional-release and release states gate movement, allocation, and shipping, with full status-change history.
Recall readiness
Lot-to-parent genealogy and a product where-used index turn a recall or mock recall into a query, not a week-long fire drill.
- Validation support for IQ, OQ, and PQ, so qualifying the system is a guided process.
- Granular role-based access, record locking, and authentication on every transaction.
- See the full mapping in our 21 CFR Part 11 breakdown.
// MORE INDUSTRIES
See it run a regulated batch.
Book a walkthrough and we'll take a sample product end to end: signed formula, batch record, quality release, and lot genealogy.