RIMS & Compliance Data ManagementCelegence2023-07-06T12:05:53+00:00
Case Study: RIMS & Compliance Data Management
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
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
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.
Get in touch today to discuss your regulatory needs by reaching out to email@example.com or contact us online.
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