Compliance Analytics Solution Enabled Compliance with Industry Best-Practice Standards

Established in 1997, the client is a world leader in developing and commercializing first-or-best-in-class therapies for rare genetic diseases. Headquartered in California, the client has operations spread across 20+ countries and 2500+ employees worldwide.

 

Background

The client’s core operation involved running cutting-edge manufacturing processes for creating drugs used in clinical trials. To manage quality assurance and quality control in its manufacturing processes, the client had implemented a quality management system, TrackWise. 

 

However, the client was unable to obtain the required insights into its quality control data at the highest and the most detailed level. This led to challenges such as: 

  • Lack of adherence to regulatory requirements
  • Long time-to-market to launch products
  • High risk of product recalls
  • High overall cost-to-quality

 

The client wanted to implement an analytics solution that would provide it with the required insights into its quality control data. 

 

Solution

DiLytics implemented an Oracle Analytics solution for GxP (Good Practices) for the client. The solution automated the transmission of data residing in the TrackWise source system to the Oracle Analytics solution (target system) and provided reports and dashboards that gave distinctive views of the data via charts, tables, and calculation results. DiLytics solution provided the following MMR metrics to the client users: 

  • Confirmed Out of Specification (OOS)/Out of Trend (OOT)
  • Product Complaint Rate
  • Deviation Rate Per Day
  • Product Complaint Closure Rate
  • Closure Rate for Deviations and Corrective Actions Preventive Actions (CAPAs)
  • Past Due Regulatory and Partner Commitments

 

Business Benefits

  • Facilitation of compliance with industry best-practice standards and Food and Drug Administration Safety and Innovation Act (FDASIA) reporting expectations
  • Ability to easily view compliance levels across sites and products from a single source and on a continual basis

 

Technical Stack

  • Source Systems: TrackWise
  • Data Integration Tool: Informatica
  • Data Warehouse: Oracle Business Analytics Warehouse
  • Reporting Tool: Oracle Analytics

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