Batch Records

Connected, Compliant and Complete

In regulated environments, batch records are more than just paperwork they are the definitive proof that every product was made according to specifications, procedures, and compliance requirements. Simploud’s Batch Records solution, as part of its integrated LIMS, transforms this process from a manual burden into a streamlined, connected workflow.

With Simploud, batch creation can be triggered automatically from a production plan, material readiness, or change control ensuring the right processes start at the right time. Manufacturing activities are guided by configurable checklists that ensure every step is followed, documented, and signed off in a 21 CFR Part 11-compliant manner.

Accelerate Readiness Without Sacrificing Control 

Testing and verification are built in. Produced materials can be linked directly to QC test results, deviations, and CAPAs, ensuring that no batch is released without complete and compliant evidence. The solution also enables the creation and management of a Bill of Materials (BOM), connecting each batch to its source materials, suppliers, and any associated, relevant items.

Because Simploud uses true many-to-many relationships, a single batch can relate to multiple materials, test records, equipment logs, and even environmental monitoring data giving Quality, Manufacturing, and Supply Chain teams a shared, real-time view.
The result: inspection-ready batch records from day one, fully integrated into your LIMS and connected to every process that matters.
Batch Records
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