The batch, end to end
Batch management and shelf-life control through production, quality and dispatch.
Pharma & life sciences
Validated processes, GMP documentation and batch management for regulated manufacturing.
Typical use cases
In pharma, the batch, the document and the audit trail have to stay together. The implementation keeps the GMP file linked to the production order, including when the landscape changes.
The file on the batch
GMP documents and audit trails linked to the batch they belong to.
Validation when SAP changes
Support for computer system validation when the SAP landscape is upgraded or moved.
Deviations on the batch
Deviations and CAPA filed against the batch they affect, so quality and production read the same case.
Vendors cleared to supply
Approved-vendor status and certificates kept current in iDMS before a material is issued to the batch.
A recall that can be answered
A batch traced forward to the customers and shipments it reached, from the same record used to make it.
Related
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