The compliance challenge
Pharmaceutical manufacturing operates under some of the most demanding traceability requirements in any industry. Every batch must be traceable from raw material receipt through dispensing, manufacturing, QC testing, packing, and dispatch — with electronic records that cannot be altered without a visible audit trail. For this manufacturer, meeting FDA 21 CFR Part 11 and WHO-GMP requirements meant either buying dedicated compliance software or solving the problem at the ERP layer.
Their previous setup used a legacy ERP for financials, a separate QMS for quality records, and paper batch manufacturing records. Reconciling a single batch across three systems took four to six hours per QA officer during audits.
Building traceability into the data layer
Instead of adding another system, the team extended their existing platform with a batch and serial number layer built directly into the stock and manufacturing modules. Every raw material receipt creates a batch record. Every production order consumes batches. Every QC result is linked to the batch, not to a separate document.
- Batch genealogy report — one click from finished goods batch to source raw material batches
- Electronic signatures — QA sign-off captured with timestamp and user credentials
- Deviation logging — process deviations linked to the batch record automatically
- Expiry management — FEFO picking enforced at the warehouse level
- Recall simulation — identify all affected batches and customer lots in under 60 seconds
Audit outcomes
In the subsequent WHO-GMP audit, the manufacturer presented all batch records electronically. The auditors requested a batch genealogy trace during the audit — the QA officer produced it in under two minutes. The audit passed with no critical observations related to documentation or traceability.
Traceability is not a feature you add at audit time. It has to be the default behaviour of every transaction in the system.
Unlimited users, no additional cost
Because the platform charges no per-seat fees, every QA officer, production supervisor, and warehouse associate has a login. That means every transaction is attributed to a real person with a real timestamp — not a shared generic account. This alone resolved the FDA 21 CFR Part 11 concern about shared credentials that had persisted under the old system.