GxP Compliance Initiative for Major Biotechnology Sponsor

The Challenge

A biotechnology sponsor needed to align its systems and operations with GxP regulatory expectations in preparation for upcoming audits and potential filings. Their internal teams lacked a consistent validation methodology, and the absence of a formal QMS introduced compliance and inspection risks across their development environment.

The Systematic Approach

Driftpin applied a risk-based CSV strategy aligned with GAMP 5 principles, focusing on critical thinking and traceability over documentation volume. We collaborated with the client’s team to build a fit-for-purpose QMS with SOPs tailored to their workflows and team structure. Our approach emphasized scalable governance, streamlined validation, and readiness for inspections.

Key Activities

• Conducted risk assessment and gap analysis against GxP requirements
• Established a tailored Quality Management System with SOPs and training
• Developed and executed validation plans aligned to GAMP 5 and CSV best practices

The Transformation

The client moved from reactive compliance practices to a proactive, inspection-ready state. Validation activities were standardized, quality processes were embedded in day-to-day operations, and internal teams gained clarity and ownership over regulatory responsibilities.

Measurable Outcomes

• GxP compliance: Full GxP alignment achieved across validated systems
• Quality governance: New QMS implemented with trained users and SOP adoption
• Audit readiness: Client passed internal and partner inspections with no critical findings

Strategic Impact

With compliant infrastructure and operational rigor in place, the client is now positioned for smoother regulatory filings and partnership engagements, reducing delays and strengthening trust with stakeholders.