Automation Studio, Access Control & Integrations
Define exactly where the ERP and its AI agents may act on their own, where a qualified human must sign, and which external systems feed the operating picture.
Automation rules
- AR-01Quarantine on goods receiptApproved
When Material received against a PO → then Create QC sample request, set lot state to Quarantine, block dispensing
Auto-execute · 1,284 executions logged - AR-02Block release on open critical deviationApproved
When Batch reaches QA Review with a linked critical deviation → then Hold batch release and escalate to Qualified Person
Auto-execute · 37 executions logged - AR-03Near-expiry re-channellingPending
When Lot shelf life drops below 120 days → then Draft FEFO allocation to tender / hospital channel
Human approval · 96 executions logged - AR-04Shortage-driven purchase requisitionPending
When MRP net requirement is negative within lead time → then Raise purchase requisition to the qualified supplier with best AI score
Human approval · 212 executions logged - AR-05Cold-chain excursion responseApproved
When Shipment temperature leaves 2–8 °C for over 15 minutes → then Quarantine the shipment, open a deviation, notify QA and the customer
Auto-execute · 14 executions logged - AR-06Credit-hold releasePending
When Customer exceeds credit limit or 60-day ageing → then Hold the sales order pending finance review
Human approval · 148 executions logged - AR-07Calibration lockoutApproved
When Instrument calibration passes its due date → then Block the instrument for GxP use and cancel scheduled tests
Auto-execute · 9 executions logged - AR-08Recall simulation nightlyMinor
When Daily at 02:00 → then Recompute batch genealogy reach and refresh recall exposure
Notify only · 231 executions logged
Integration bus
- MES / SCADA — Lines 1–5ApprovedManufacturing execution
Batch orders down, yields and OEE up · 30 s polling
- LIMS — QC laboratoryApprovedQuality
Sample results, OOS flags and COA generation
- GS1 serialization / EDA track & traceIn ReviewRegulatory
SGTIN commissioning, aggregation and government reporting
- Cold-chain IoT loggersApprovedDistribution
Live temperature telemetry per shipment and cold room
- Bank & e-invoicing portalPendingFinance
AR settlement matching and tax authority e-invoices
- Supplier portal & EDIApprovedProcurement
PO confirmations, ASN, COA exchange with 34 suppliers
Roles, permissions & e-signature policy
| Role | Scope | E-signature |
|---|---|---|
| Qualified Person (QP) | Batch release, recall decision, regulatory sign-off | Critical |
| QA Reviewer | Deviation classification, CAPA approval, EBR review | Critical |
| QC Analyst | Sample testing, result entry, OOS initiation | Critical |
| Production Supervisor | Batch execution, stage completion, yield entry | Critical |
| Warehouse Operator | Goods receipt, picking, FEFO allocation execution | Low |
| Finance Controller | Credit limits, costing, month-end close | Low |
| Commercial Manager | Pricing, tenders, customer master | Low |
All privileged actions are logged to the ALCOA+ audit trail with user, role, timestamp, previous value, new value and reason for change — matching 21 CFR Part 11 and EU GMP Annex 11 expectations.
Records & transactions
Automation rule
No records posted in this module yet. Use “New record” to create one — it is saved to the shared database with an audit entry, recomputed into the KPIs and alarms, and fed to the AI agents as live context.