The challenge
A solid-dose plant faced the familiar pharmaceutical split: the business layer (ISA-95 level 4: orders, procurement, finance) and the operations layer (level 3: execution, quality, batches) lived apart, and audit preparation meant weeks of reconciling them. The register of obligations (EU/UK GMP, the Human Medicines Regulations, FMD serialisation) sat in a spreadsheet nobody trusted.
Our approach, mapped to ISA-95
WAJD Forge runs levels 3 and 4 as one system, so the reconciliation problem disappears rather than getting easier. Production scheduling, dispatching, execution and tracking (the level 3 functions the standard names) post their financial consequences to the same ledger the accountants read. The regulation register is part of the plant, seeded for the sector, with local rules superseding national superseding international.
Quality is in the line, not after it: each station samples its processes, mandatory steps and mandatory viewing (drawings, method photographs) gate the work, and end-of-shift steps gate the handover itself. Nothing held ever reaches finished goods without a disposition, and scrap dispositions restate OEE for the affected period, so the number the board sees is the number quality signed.
What the auditor sees
The audit trail is append-only and tamper evident: every entry hash-chains the previous, and the chain is verified in front of the auditor at report generation. Batch genealogy is recorded at consumption, so a suspect raw batch traces to supplier, goods receipt, exposure window, finished batches, shipments and customers in one call. The audit report itself is generated from live records with a signature block, and files itself under the plant's policies, so the evidence trail includes the report.
The outcome
Audit preparation stopped being a project. The recall drill runs in seconds instead of days. And because the same discipline produces the CEO's numbers, the plant stopped maintaining two versions of the truth.