Case Study: Schiff Nutrition International achieves FDA Part 111/Part 11 compliance and streamlined batch-record ERP integration with MasterControl

Schiff Nutrition International - Customer Case Study

Schiff Nutrition, a maker of branded and private‑label dietary supplements, faced growing problems with large, paper‑style batch records and a homegrown document system that lacked Part 11 controls (audit trails, versioning, e‑signatures) and was hard to edit. They also had a workflow disconnect between their JD Edwards ERP and the MasterControl EDMS, leaving work orders unable to access the correct “recipe” documents and creating compliance and efficiency risks.

Schiff worked with Malcom Associates and consultant George Benevento to convert batch records to editable Word templates managed in MasterControl, then purchased MasterControl’s API toolkit and built a .NET integration to link JDE and MasterControl. The system automatically generated work‑order‑specific copies, applied headers, vaulted documents for retention, and removed originals as needed—delivering Part 111/Part 11 compliance, a seamless user experience with no retraining, fewer errors, and faster, more secure batch record management.

Schiff Nutrition International

George Benevento

Consultant and Batch Records Documentation Expert