Scalable MSAT validation support for seamless compliance & efficiency

Qualification & Validation

Pharma

A global pharmaceutical leader specializing in sterile manufacturing and biopharmaceutical production faced fluctuating validation demands across multiple teams. To maintain compliance and operational efficiency, the client required a scalable external team to adapt to shifting workloads.

QbD Group deployed 12 validation engineers, managed by a dedicated Single Point of Contact (SPOC), ensuring seamless collaboration, resource scalability, and regulatory compliance across validation processes.

Key Compliance Steps for Pharma Software During Operations

About the client

The client is a global pharmaceutical leader specializing in innovative medicines and cutting-edge therapies. Its site plays a critical role in sterile manufacturing and biopharmaceutical production for global markets.

Challenge

Managing fluctuating validation demands

With process validation, sterilization validation, and software validation spanning multiple teams, the client faced fluctuating validation demands. To maintain compliance and operational efficiency, they required a scalable external team capable of adapting to shifting workloads while ensuring quality and regulatory standards were met.

Discover our approach

Approach

A structured and flexible validation team

To address this challenge, QbD Group deployed 12 validation engineers, managed by a dedicated Single Point of Contact (SPOC) to ensure seamless collaboration and adaptability. The approach included:

Rapid knowledge transfer and issue escalation for uninterrupted workflows
Efficient up/downscaling of resources based on real-time workload fluctuations
Bi-weekly steering committee meetings to assess performance and optimize resource allocation

Result

Regulatory compliance & operational continuity

By implementing this flexible and structured approach, the client achieved:

✅ Seamless validation support that scales with changing demands
✅ Regulatory compliance across all validation processes
✅ Operational continuity through optimized resource allocation

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