Digital Transformation With Cloud-Based Software Solutions Ensures FSMA Compliance – It All Starts With Data

  • Leverage technology/software to meet the traceability critical tracking events (CTEs) and key data elements (KDEs) of the FDA FSMA guidelines
  • Greatly improve end-to-end traceability by digitizing and documenting both manual and automated processes with electronic work process management
  • Accurately document what happened during all phases of production to ensure compliance with new and existing regulations and use this data for continuous process improvement.
  • Achieve the benefits of a cloud-based Manufacturing Execution System (MES): “right first time”, improved product quality, lower production waste, scrap and recall.
  • Overlay resource consumption data with quality context to quantify and provide visibility to the environmental cost of poor quality and non-conformance.

Vikram Mankar
Principal Product Manager
GE Digital

Vikram is the Principal Product Manager for GE Digital with a focus on Process/CPG/F&B industries. Vikram brings 19 years of experience in product management, delivery and sales of manufacturing software systems. He started his career with EDS at GM’s Linden Truck plant. In 2006 he joined GE and has spent the last 17 years in different roles focused on Manufacturing Operations Management across multiple industries.