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CASE STUDIES

Pharmacovigilance Health Assessment

Background Information

A mid-size pharma and medical device company using Oracle Argus to track and report Adverse Events.

This company leverages a solution provider to manage their Pharmacovigilance (PV) systems and infrastructure.

Key Problems

Since Argus, and really all of the PV solutions on the market today, are extremely complicated to manage and maintain, it is very easy to get out of sync with your configurations. It is advisable (read: imperative!) that all companies periodically take a deep dive look into the systems’ configurations, processes and procedures to ensure everything is still up-to-date.

Daelight’s Solution

Daelight assessed the customer’s PV configurations and reviewed the supporting procedures to provide an overall “configuration management health analysis.” Based on that analysis, Daelight made recommendations on process and technical changes to be made to the database and corresponding procedures, with the ultimate goal of maintaining a more pro-actively controlled database.

Project Objective

Continuous Improvement (vs. Punitive Outcome): Processes and technology can and should be reviewed periodically to seek out ways to refine and improve those processes.

Project Scope

  • Configuration Deep Dive – Technical (database level)
  • Configuration Management – Processes and Procedures
  • Change Control Analysis – Processes and Procedures
  • Compliance Tracking – Processes and Procedures
  • User Access and Management – Processes and Procedures
  • Data Security – Processes and Procedures

Results

Final Deliverables included:

  • Executive Summary
    • In a PowerPoint format, the client received an outline of all of the risks and issues, categorized by subject matter (configuration, process, etc) and organized by level of priority
    • Each risk and issue included our recommended next steps
  • Detailed Recommendations
    • The initial executive summary led into an in-depth document that takes a very deep dive into many extremely detailed recommendations on potential configuration updates (data anomalies, missing/inaccurate rules, etc)
  • Actionable Insights
    • The customer was able to take these findings, along with each risk and issue’s priority and recommended fix, into the portfolio planning process to decide what to fix and when.