Case Study: RIMS & Compliance Data Management

Project Summary:

A global pharmaceutical company needed to enhance operation excellence of its operating platforms aimed to improve the current business environment by effectively managing global regulatory data and meta data including xEVMPD and OMS/RMS maintenance services in EEA.

Celegence Solution & Approach:

To achieve these objectives, the company turned to Celegence with multiple year association, as an extension of its own internal business operation analysis team to manage the following:

  • Establish a Center of Excellence with blended team of onshore and offshore resources to manage regulatory data in RIMS, xEVMPD, OMS/RMS compliance data on behalf of the company
  • Regulatory data emerging out of global business operations analysts and affiliates is received by Celegence CoE team and same is managed by collating into RIMS and other applications
  • Defining templates and QC checklist to ensure data is aligned with established business processes, SOPs, Wis and other guidelines

  • Enable robust performance monitoring and control through transparent KPI & SLA dashboards

Project Achievements

Through its CoE working model, Celegence has managed regulatory data and metadata effectively to ensure the downstream applications have appropriate data from RIMS application with quality outcomes to this pharma client. These include:

  • Performance measurement through KPIs
  • Improvement in data quality thus ensuring appropriate data is made available to the downstream applications/engines
  • Timely delivery performance aligned with compliance requirement despite stringent timelines

  • Reduction in total cost of ownership including resources, tools and other operational cost
  • Improved compliance based on guidance from Celegence’s regulatory experts

Project Success:

Key to the success of the partnership was Celegence’s expertise with Regulatory affairs/operations and knowledge of RIMS tool to organize the data. This helped to quickly ramp up the project and ensure quality outcomes from the CoE team. Furthermore, having a thorough understanding of business processes resulted in adhering to the agreed KPI.

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