Updated October 2026
Consultare, an SAP Gold Partner, implements SAP Business One with ProcessForce for small and mid-sized pharmaceutical companies that need lot traceability, expiry control, and electronic records built for 21 CFR Part 11.
SAP Business One supports Part 11 through configurable electronic signatures at critical production and quality steps, audit trails that log every action with user identity and timestamp, and role-based access controls.
If you run a pharmaceutical company, you probably recognize at least three of these.
Records live in binders, spreadsheets, and inboxes, so preparing for an FDA inspection means days of pulling documents together.
Batch approvals and quality dispositions are signed by hand or by email, with no electronic audit trail behind them.
Following a lot from supplier receipt to finished goods shipment takes hours of searching instead of one report.
Newer material gets picked while older lots approach expiration, leading to write-offs and compliance risk.
Inspections are logged separately, and material can move forward before approvals are confirmed.
Each system change means more documentation, so the team avoids improvements it needs.
Each of these is a symptom of the same problem: production, quality, and inventory records live in different places. Here is what changes when they run in one system.
| What you manage | Without an integrated system | With SAP Business One and ProcessForce |
|---|---|---|
| Electronic signatures | Approvals signed on paper or by email | Configurable electronic signatures at critical production and quality control steps |
| Audit trail | Changes reconstructed from memory and paper | Tamper-evident audit trails that log every system action with user identity and timestamp |
| Access control | Shared logins and spreadsheets anyone can edit | Role-based access controls that restrict unauthorized changes |
| Lot traceability | Hours of searching across systems | Bidirectional lot genealogy, from supplier lot to finished goods and back, as one report |
| Expiry management | Older lots expire on the shelf | First Expired, First Out (FEFO) allocation at picking and production, with expiration alerts |
| Quality control | Inspections on paper, logged separately | Inspection checkpoints in goods receipt and production orders, with quarantine until results are approved |
| Formulas and batches | Approved specifications kept in documents | Approved formula versions with defined tolerances, and deviations flagged during the batch |
| Supplier paperwork | Invoices and delivery notes typed in manually | MANGO AI-powered OCR scans and posts invoices and delivery notes into SAP Business One |
SAP Business One is the operational backbone. It holds purchasing, inventory, production, quality, and financials in one system, so every lot, batch, and approval connects to the same record.
ProcessForce adds process manufacturing depth. CompuTec’s ProcessForce extends SAP Business One with batch control and traceability, quality control, complaint management, product data management, ingredient declaration, and handheld data collection. Learn about ProcessForce
Consultare configures, implements, and supports it. We set up the electronic signature, audit trail, and access controls your quality team needs, configure lot, expiry, and inspection rules around your products, and stay on as your outsourced ERP team through our Professional Services Agreement (PSA).
Reduce the regulatory risk that can stop production, with one implementation partner accountable for the result.
Cut write-offs from expired stock and failed batches, and keep a complete audit trail behind every financial and quality record.
Pull a lot genealogy or an audit trail in minutes, and stop rebuilding records before every inspection.
Many use SAP Business One, SAP’s ERP for small and mid-sized businesses, extended with a process manufacturing solution for batch control, quality, and traceability. Consultare implements SAP Business One with CompuTec’s ProcessForce for pharmaceutical companies that have outgrown spreadsheets or entry-level accounting software.
Yes. SAP Business One supports 21 CFR Part 11 through configurable electronic signatures at critical production and quality steps, tamper-evident audit trails that record every action with user identity and timestamp, and role-based access controls. Part 11 compliance also depends on your procedures and system validation, which your quality team owns. Consultare configures the controls to fit those procedures.
Yes. Every goods receipt, production consumption, and inventory movement is recorded with lot references. The traceability report builds a complete genealogy on demand, forward from a raw material lot to finished goods, or backward from a customer complaint to the source lot.
SAP Business One applies First Expired, First Out (FEFO) logic at picking and production allocation, so the lot with the earliest expiration date is used first. Expiration alerts notify procurement and production teams before material becomes unusable.
ProcessForce is CompuTec’s process manufacturing solution for SAP Business One. It adds product data management, bills of materials, batch control and traceability, quality control, complaint management, ingredient declaration, product costing, production scheduling, and handheld data collection.
Cost depends on the number of users, the SAP Business One license types, whether you need ProcessForce, and how much configuration your products and procedures require. Consultare provides a tailored estimate after a short discovery conversation.
SAP Business One is built for small and mid-sized businesses, while SAP S/4HANA is SAP’s ERP for large enterprises. Our SAP Business One vs. SAP comparison explains the differences.
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