Case Study: Schiff Nutrition International achieves rapid FDA compliance and integrated batch-record automation with MasterControl

How MasterControl is Streamlining Our Software Systems

Schiff Nutrition International faced new FDA quality-control requirements that made its custom batch-record program — built on a JD Edwards ERP that lacked a native batch-record system — noncompliant. Updating the in-house system or upgrading the ERP would have required lengthy programming, validation and training, and a purchased nonintegrated solution would have created workflow gaps across operations.

Schiff implemented MasterControl, using MS Word for document routing and the MasterControl API to generate, number and extract approved batch records (over 900 records for 300+ products), apply work-order numbers, print records and archive copies in a separate vault. The integration avoided an ERP upgrade, was programmed in under two weeks with minimal training, delivered audit trails and e-signatures, and met the new FDA requirements while keeping costs and maintenance low.

Schiff Nutrition International

Tom Gosse

Document Control Management