Governance, risk & compliance
Authorization design, segregation of duties and GxP controls that apply identically in Pharma Mode and SAP Model.
Segregation of duties
| ID | Rule | Risk | Status |
|---|---|---|---|
| SOD-01 | Create supplier vs. approve supplier payment | Critical | Enforced |
| SOD-02 | Create purchase order vs. post goods receipt | High | Enforced |
| SOD-03 | Record QC result vs. post usage decision | Critical | Enforced |
| SOD-04 | Maintain material master vs. approve change request | High | Enforced |
| SOD-05 | Create sales order vs. release credit block | High | Monitored |
| SOD-06 | Batch release vs. batch manufacturing confirmation | Critical | Enforced |
Roles & critical transactions
| Role | Transactions | Users |
|---|---|---|
| Production Planner | PP-PLORD, PP-ORDER, MM-STOCK | 12 |
| QC Analyst | QM-RESULTS, QM-LOT (display) | 24 |
| QA Release Officer | QM-UD, PP-ORDER (display), Batch release | 6 |
| Buyer | MM-PR, MM-PO-CREATE, MM-SOURCE | 9 |
| Warehouse Operator | MM-MATDOC, EWM-STOCK, Putaway/Picking | 31 |
| Financial Accountant | FI-DOC, FI-AP, FI-AR | 8 |
Application controls
- CTL-01 Electronic signature on release
Every usage decision and batch release captures user, time, meaning and reason (21 CFR Part 11).
- CTL-02 Change documents on master data
Regulated fields (shelf life, storage, specification) require an approved change request.
- CTL-03 Release strategy on purchasing
Value-based approval levels with quality agreement validity check on the supplier.
- CTL-04 Blocked stock enforcement
Rejected batches cannot be picked, delivered or invoiced by any process.
- CTL-05 Audit trail immutability
ALCOA+ trail written on every posting, reversal and approval; reversal never deletes.
Records & transactions
Change control · Executive decision log · Deviation
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.