Traceability and Compliance

Key Features

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  • FDA, ISO 9000, supplier audits
  • Audit tracking
  • Supplier audit results and Certifications
  • Regulatory documentation
  • Certification submittal with reminders
  • Corrective Action Preventive Action (CAPA) planning
  • Corrective Action Requests (CARs)

Plant floor data is often logged on clipboards and stored in binders. When this occurs required action or data is missed, and downstream problems occur. At the same time, audits are slow and stressful, when data is not digital.

Filed paper can’t be mined to provide insight for process improvement. While safety plan monitoring, corrective actions, and verifications consume resources in both time and people.

Key Benefits

  • Product genealogy
  • Forward and backward lot/serial material traceability
  • Parts/ingredients into products/assemblies
  • Joining and splitting lots
  • Yield and trend analysis of production results
  • Customer Certificate of Analysis Generation
  • Supply chain parent/child relationships of material and processes

  • Solution Overview

    Traceability

    Elemica Traceability and Compliance provides supply chain partners the ability to share global product quality information. The solution is inclusive of production facilities with all feeding operations and processes.

    Advance Ship Notices (ASNs), tied to material shipments with their e-COA and batch records provide lot and serial number traceability. The solution is accessible to trading partners and handles complex product flows for status of materials performance. Elemica Traceability and Compliance addresses quality from raw materials to deliverable goods.

    Product genealogy based on parent and child relationships is enabled by tracking ingredient and component lot mixing at every step. Combined with the shipment criteria, complete supply chain visibility is achieved.

    Compliance

    A regulatory compliance system enables an organization to handle quality risks, ensure transparency, automate assignments, reduce compliance costs, and utilize trending to improve operations. It helps protect brand reputation affected by recalls or customer complaints.

    Managing compliance documentation and activities across the supply chain is a core strength of Elemica Traceability and Compliance. Before certifications expire, the solution alerts the supplier and manufacturer that action is needed.

    Elemica Traceability and Compliance helps companies drive continuous improvement by providing immediate insight into plant floor and quality operations. When issues arise, notifications empower employees to act. Corrective Action Requests (CARs) are generated and are visible to users.