Case Study: GxP Compliance Initiative for Major Biotechnology Sponsor

How a Major Biotechnology Sponsor Partnered with Driftpin Consulting

Vertex collaborated with Driftpin to implement GxP compliance processes, ensuring seamless regulatory alignment and operational excellence.

Background

The client, a biotechnology corporation, needed to align its systems and processes with GxP requirements to meet regulatory expectations and improve efficiency.

Objectives

• Achieve compliance with GxP regulatory frameworks.
• Streamline validation processes for clinical systems.
• Establish robust quality management practices.

Scope of Work

System Validation and Testing

• Developed and executed validation plans aligned with GAMP 5 principles.
• Ensured risk-based approaches to CSV (Computer System Validation).

Quality Management Implementation

• Designed and implemented a tailored Quality Management System (QMS).
• Created SOPs and training modules for team alignment.

Solutions and Outcomes

• Achieved GxP compliance, reducing regulatory risk.
• Enhanced system reliability and operational efficiency.