GMP batch records
The batch record assembled from the production order as it runs: materials issued by lot, steps completed, checks passed, signatures captured.
Pharmaceutical ERP that keeps GMP batch records, formulas, lot genealogy, quality release and serialization data in the same system as purchasing, inventory and financials.
Why pharma and nutraceutical makers call us
Most small and mid-size pharmaceutical and nutraceutical manufacturers come to us at the same point: the batch record is paper, the formula is a spreadsheet, quality release is a signature on a form, and lot genealogy is reconstructed when an auditor or a recall demands it.
SAP Business One for pharmaceutical manufacturing replaces that patchwork with one system for formulas and batch production, lot genealogy, expiry and quarantine, QC testing and release, serialization data, purchasing, inventory, sales and financials, with the audit trail built in.
Requirements
Eight areas where pharma ERP software earns its keep, and the ones we configure first.
The batch record assembled from the production order as it runs: materials issued by lot, steps completed, checks passed, signatures captured.
Formulas by weight and volume with potency-adjusted quantities, yield and scaling to the batch.
Every raw material lot traced into every batch and out to every shipment, in both directions, in minutes.
Shelf life on every lot, quarantine until QC release, and first-expired-first-out picking.
Test results against the lot, release or reject decisions, and the certificate of analysis printed from the system.
Who changed what and when on every controlled record, with electronic signatures where the procedure requires them.
Serial and lot data held and exchanged for the transactions the Drug Supply Chain Security Act covers.
Approved suppliers by material, deviations and CAPAs tracked to closure.
Pharma ERP modules
Formulation, production, quality, inventory, purchasing, sales and distribution, and finance run in one SAP Business One company database rather than as separate modules stitched together, so a lot number means the same thing in the warehouse, the lab and the ledger.
SAP Business One supports compliance; validation stays with the manufacturer. We document the configuration so the IQ, OQ and PQ package is straightforward.
The Third Wave build
SAP Business One already covers formulas, production, quality, inventory, purchasing, sales and financials. What makes it a pharma ERP is the configuration and the add-ons around it. A typical Third Wave pharma build includes:
Every build starts with your formulas, your quality procedures and your lot rules, not a template.
Sub-sectors
Different products, the same operating problems: batches that have to trace, releases that have to be signed, and documents that have to match.
Formulas, batch records and lot genealogy under GMP.
Potency, expiry and label claims held on the item and the lot.
Customer-owned formulas, batch records per customer, and job costing per run.
Zeus Scientific, an FDA-regulated diagnostics manufacturer, runs production tracking and shipping on SAP Business One.
Lot and expiry tracking, serialization data exchange and recall reports across every customer shipped.
Recipes, allergens and FEFO for makers on the food side of the line.
Client results
FDA-regulated production on SAP Business One.
Success StoryZeus Scientific
Medical diagnostic testing manufacturers like Zeus Scientific are highly regulated by the Food and Drug Administration. This means they need to keep track of a lot of data, and if it isn’t automated, the headcount—and headaches—go way up.
Client reviews
They provided automated programs that have greatly reduced manual labor time, reduced errors, and simply provided data we otherwise would not have had access to easily.
They are responsive, consistent, and thorough; they are able and willing to examine the underlying business process to best understand which technological options will address the true need.
Third Wave Business Systems has been a highly valued partner, consistently helping us solve complex business challenges. They streamline operations, adapt solutions to our specific needs, and provide timely support that minimizes downtime and maximizes efficiency.
How to choose
Most lists of the best ERP for the pharmaceutical industry rank vendors. The better test is whether the system can run the batch record as production happens and trace a lot in minutes. Five questions settle it.
From the production order as it runs, or from a binder assembled afterwards. Only one of those survives an inspection.
Ask for a mock recall in the demo, on your own materials.
Nothing picks until the lot is released, enforced by the system rather than by a label.
Licenses, implementation, add-ons and hosting. Our SAP Business One pricing guide lays out the ranges for a pharmaceutical manufacturer and what moves them.
Validation and the migration of formulas and lot history move the date more than company size. Our implementation timeline guide covers the phases.
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