Challenge

For food additives and pharmaceuticals, manufacturing must be documented, and all products need FDA approval. A nutritional ingredients manufacturer needed to maintain these regulatory standards as well as gain transparency into its manufacturing operation.

Solution

PlantSharp’s Traceability module supports the needs of a highly regulated manufacturing plant by ensuring that the plant meets the strict regulations of the FDA.

  • The PlantSharp Traceability module creates an audit trail providing visibility into what goes into every product, every step of the manufacturing process.
  • Batch tracking precisely tracks the batches of all ingredients, ensuring that they are acceptable along with all other batches comprised of the same ingredients.
  • The suite provided the plant managers with confidence in their abilities to meet the regulations and improved the quality level of the product almost 100% of the time
  • Flexible and quick response to recipe changes mandated by the FDA
  • Solution compliant with ISO 90001 and CFR Part 11

Results

“With our highly unique production process, we needed a smart industrial software that was flexible enough to meet our needs,” said the COO. “PlantSharp was one of the only manufacturing software suites that could truly support our unusual and highly regulated manufacturing processes with hardly any ramp up time.”