RxLogix Solutions - PV E2B-Converter

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Leverage RxLogix PV E2B-Converter tool to achieve the upcoming EMA E2B (R3) Compliance in November 2017 with your existing Safety system. Recruit RxLogix E2B experts to lead the way, as we were part of the team that developed the core Argus Interchange functionality.

PV E2B-Converter is a must-have solution for non-E2B (R3) compliant PV systems. It seamlessly allows companies to be compliant with E2B (R3) without having to go through an expensive and time-consuming upgrade.

This solution allows companies to convert E2B (R3) to E2B (R2) and vice-versa with minimal loss of data and continue to exchange messages with agencies as they mandate E2B (R3) compliance.

Key Features

  • Backward and Forward Compatibility (BFC) between E2B (R3) & E2B (R2) formats.
  • Additional E2B (R3) data elements are automatically populated incorrect existing or additional User Defined fields in the Case to ensure minimal data loss and maximum efficiency.
  • Source documents (pdf, xls, doc, jpg, etc.) from incoming E2B (R3) reports will be retained in the Case for future reference and verification.
  • Agency specific adaptations to ensure compliance to agency specific regulations.
  • Side by Side in-line tag comparison between E2B R3 & E2B R2 XML data elements.
  • Detailed tracking of all E2B files processed by the PV E2B-Converter

Key Benefits

Benefits -RxLogix
  • Compliance - Ensures compliance with the three major global regulatory authorities (FDA, EMA, and PMDA) which are expected to adopt the E2B (R3) standards but at different timelines.
  • Cost Saving - Cost efficient alternative to an E2B (R3) compliant safety system upgrade, until a fully compliant (with FDA, EMA and PMDA) and stable safety system version is available.
  • No Data Loss - PV E2B-Converter ensures no loss of business data elements while converting files from E2B (R3) to E2B (R2) and vice-versa. It leverages a combination of E2B extension (E2B+) feature, User Defined as well as existing fields in the safety system to accommodate the additional data elements. Also, original incoming E2B (R3) ICSR XML file and other source documents will be available in the corresponding case.
  • Monitoring of E2B Conversion Process - Users can track all the E2B files processed by the PV E2B-Converter. They can also review side by side inline comparison of E2B (R3) & E2B (R2) XML data elements in a user-friendly interface.
  • Seamless Process Integration - Users can continue accepting and submitting cases received via E2B (R2) or E2B (R3) with no change to the current process.
  • Rapid Deployment - PV E2B-Converter has been pre-validated with widely used safety systems. RxLogix works closely with the client team for rapid implementation and continuous support for hosted or on-site deployments.