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  • Track & Trace Validation Documentation for Cost Effective Easy Integration

    In-Sight Track & Trace Conforms to FDA 21 CFR Part 830 UDI GS1 validation requirements for medical devices and various validation standards for pharmaceutical packaging

  • In-Sight Track & Trace validation Documentation is used to validate Track & Trace installations across all of your production lines and facility locations. This documentation was developed in accordance with the GAMP 5 approach to the specification and verification of a category 4 validated system. Complete the form on the right to see the contents of this documentation.

    Simplification of Validation Procedure

    • The IQ/OQ Document serves as a template for the Installation Qualification and the Operational Qualification used for the validation of In-Sight Track & Trace v2.0.x in accordance to the predetermined functional requirements and design specifications as outlined by GAMP5 Validation Procedures.
    • The FS/DS document is the Functional Specification and Design Specification, providing a general description of the In-Sight Track & Trace software and its functions, system requirements and overall system purpose in development practice.
    • The TMX document is a Traceability Matrix providing a mapping of all requirements outlined in the Functional Specifications to the Design Specifications, and linking them to the appropriate Installation Qualification and Operational Qualification steps. This is used to ensure all requirements have been implemented and tested prior to deployment.
  • Track & Trace validation documentation

    Track & Trace validation documentation reduces the cost of validation for the medical devices and pharmaceutical industry. Find out what you need to know!

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