Industry: Pharmaceuticals
Service: Validation & Compliance
Background A leading provider of clinical database design and management, medical education, and clinical trial services for the pharmaceutical industry.
Business Issue The Company’s lack of controls caused disruption to their two key systems and raised concerns regarding overall process controls required by government regulations. The Company was also undergoing a merger of competing IT groups under a single business entity, creating the need for streamlined CSV processes and support procedures.
The Objective A System Compliance Investigation to identify underlying root causes of system availability failures. Software Development Life Cycle (SDLC) Simplification and Harmonization by analyzing current system support and practices of competing internal organizations.
The Solution System Compliance Investigation for availability issues:
- Arbour interviewed Management, Quality Assurance, Business, and IT personnel to understand process inputs and associated outcomes that resulted in loss of system availability.
- Performed a Root Cause Analysis for each system by analyzing outputs demonstrating multiple system and process administration failures.
- Presented to Management the Root Cause Analysis outcomes with suggestions to address shortcomings and a plan to alleviate availability issues.
SDLC Simplification and Harmonization
- Arbour interviewed Management, Quality Assurance, Business, and IT personnel to review existing system support and SDLC materials from the two internal organizations.
- Developed Quality Agreements that outlined coordination of support services owned by internal IT organizations with a focus on efficient processes and reducing conflicts.
- Developed a scalable and sustainable SDLC to be used across the client enterprise.
- Produced SDLC supporting materials and documentation templates.
- Facilitated multi-day training sessions for application of the harmonized SDLC