Client Overview
A leading French multinational pharmaceutical company required extensive support for global GxP compliance audits involving a large network of vendors and service providers. The organization needed a scalable and efficient audit support model to ensure compliance with global quality and Regulatory expectations across multiple operational functions.
To strengthen audit readiness and streamline compliance activities, the client partnered with Freyr Solutions for end-to-end GxP compliance audit support services.
Background
The client managed a broad network of vendors supporting pharmaceutical operations across multiple regions and functions. Ensuring vendor compliance with global GxP standards was critical to maintaining product quality, Regulatory compliance, and operational continuity.
Due to the increasing number of vendors and audit requirements, the organization required a structured approach to audit planning, execution, documentation review, and compliance tracking. The client sought expert support to manage large-scale audit activities while maintaining consistency and quality across audit processes.
Services in Scope
Global GxP compliance audit support
Vendor qualification and audit management support
Audit planning and coordination activities
Audit documentation review and compliance verification
• CAPA tracking and follow-up support
Regulatory compliance assessment
• Audit readiness and quality support
End-to-end vendor audit coordination services
Challenge
The client encountered several operational and compliance-related challenges while managing large-scale vendor audits:
More than 90 vendors required audit oversight and compliance assessment
Coordinating audits across multiple regions and operational functions was complex
Maintaining consistency in audit execution and documentation review was challenging
High audit volumes increased pressure on internal quality and compliance teams
Tracking audit observations and CAPA activities required structured coordination
Manual audit management processes created risks of delays and inconsistencies
The client required efficient audit execution while ensuring adherence to global GxP standards
These challenges impacted audit readiness, operational efficiency, and vendor compliance management activities.
Solution
1
Structured Global Audit Management Framework
Freyr established a comprehensive audit support framework to manage audit planning, execution, documentation review, and follow-up activities across the client’s global vendor network.
2
Dedicated Vendor Audit Support
Specialized teams coordinated audit activities for multiple vendors simultaneously, ensuring timely execution and standardized audit processes across regions.
3
Compliance-Focused Documentation Review
Freyr implemented detailed audit documentation review and compliance verification processes to ensure alignment with global GxP requirements and quality standards.
4
CAPA Tracking and Follow-Up Support
A structured tracking mechanism was established to monitor audit observations, CAPA implementation activities, and compliance closure timelines efficiently.
Impact
Freyr’s GxP compliance audit support enabled the client to strengthen vendor oversight, improve audit readiness, and streamline global compliance management activities.
Successfully supported audits for 90+ vendors across global operations
Improved consistency and efficiency in audit execution and documentation review
Enhanced vendor compliance oversight and audit readiness
Streamlined CAPA tracking and follow-up management processes
• Reduced operational burden on internal quality and compliance teams
Improved coordination and visibility across global audit activities
Strengthened adherence to global GxP standards and quality expectations
The engagement helped the client establish a scalable and efficient global audit support model while enhancing vendor compliance management, operational efficiency, and Regulatory readiness across its pharmaceutical operations.
