Life Sciences Manufacturing with CompuTec

CompuTec ProcessForce supports digital production records within SAP Business One. Every Manufacturing Order can carry a complete record of materials issued, operations performed, time booked, and outputs received. All system changes are logged with a time stamp and user record, providing a transparent audit trail. These capabilities are relevant in environments where GMP principles apply. Specific compliance requirements should be verified with your implementation partner and regulatory team.

FDA 21 CFR Part 11 and EU GMP Annex 11 have specific requirements around electronic records, audit trails, access controls, and electronic signatures. CompuTec ProcessForce supports digital production records and audit trail capabilities within SAP Business One. CompuTec WMS supports electronic signatures at the warehouse transaction level. CompuTec solutions have been used by manufacturers operating in FDA-regulated environments. Whether they meet your specific Part 11 or Annex 11 requirements depends significantly on your implementation, configuration, and internal processes. We recommend discussing this with us directly or your implementation partner.

Batch data can be recorded at every stage from raw material receipt through production to customer delivery within SAP Business One. Forward and backward batch tracing is available at any point. You can trace a finished product back to its raw material sources or trace a raw material batch forward to every finished product it contributed to. Batch statuses can be updated simultaneously across multiple batches, supporting containment when a quality issue is identified.

Yes. Serial numbers can be assigned to individual items within a batch based on configurable templates, with serial number data recorded through production and warehouse processes. CompuTec WMS supports packing and repacking of serialized batches at the warehouse level using barcode scanners, with all transactions recorded in SAP Business One.

BOM revisions can be assigned lifecycle statuses (Active, Engineering, or Phased Out), giving manufacturers a structured way to manage which formulations are available for production. Multiple revisions can be active simultaneously. When a change is required across multiple products, the Mass BOM Update tool can apply it simultaneously, with changes saved as new revisions to preserve existing records.

When a quality control test fails, a Non-Conforming Materials Report can be generated to formally document the non-conformance, the affected material, defect codes, and the corrective action required. Complaints from customers, suppliers, or internal teams can also be recorded and linked to the specific batches involved, supporting root cause investigation through the batch traceability tools.

Yes. The Quality Plan in CompuTec ProcessForce reflects the ISO 2859-1 norm for sampling procedures for inspection by attributes, allowing quality control test pools to be generated based on the norm's acceptance rules and business partner ratings. This supports structured statistical sampling approaches relevant in regulated life sciences environments.

Quality control test protocols can be configured for incoming raw materials per item and supplier, with results linked to each delivery batch. Inspection frequency can be adjusted based on supplier rating, supporting a risk-based approach to incoming material control. The Supplier Scorecard evaluates supplier performance across quality, delivery accuracy, and timeliness, giving procurement teams a documented basis for supplier qualification decisions.

Yes. Each BOM revision has its own costing record, allowing the cost of alternative formulations to be calculated and compared independently. Each Manufacturing Order can carry both planned and actual cost data, supporting cost analysis and variance visibility per production run. Cost simulations can also be run using separate cost categories without affecting live production valuations.