Validation, Qualification & Certification

Get to validated production faster with a complete, compliant CQV process for your pharmaceutical machinery, covering IQ, OQ, and PQ every step of the way.

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Accelerate your path to market with agile qualification that eliminates rework loops and secures a seamless, reliable route to regulatory compliance.

Our experts create test protocols, execute qualification steps, and document results. By identifying issues early, we minimize timeline risks and ensure your machine reaches operation faster with clear, auditable documentation.

Benefits

Faster qualification cycles

Shorten your time to market by reducing testing and rework loops through an agile qualification framework that prioritizes efficiency.

Improved project timelines

Reach Performance Qualification and market readiness sooner with streamlined workflows that eliminate traditional scheduling delays.

High documentation quality

Secure your operations with clear, audit-ready evidence and documentation that meets the highest regulatory standards.

Stronger risk mitigation

Eliminate execution gaps by utilizing controlled dry runs to identify and resolve issues before formal regulated testing begins.

Reduced resource consumption

Optimize your team's efforts through better test leveraging and fewer repetitions, focusing resources where they add the most value.

Transparent acceptance criteria

Maintain total project clarity with predictable criteria and traceability from initial design documentation to final execution. 

Our services

Scalable qualification and validation packages

We provide flexible engagement models ranging from full agile project management to specific documentation support, ensuring your unique regulatory and timeline requirements are met. 

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    Standard Qualification Package

    Full creation and execution of IQ/OQ/PQ protocols, test scripts, result logs, deviation management, and final summary reporting. 

  • a Körber employee working on qualification package services

    Agile Qualification Package

    Shorter time to PQ through early software freeze and leveraging FAT/SAT results to reduce repetitive testing and stabilize execution sooner.

  • a Körber employee working on documentation support

    Documentation Support

    Get expert-authored protocols ready for your team to execute with confidence.

  • a Körber employee working on execution support

    Execution Support

    Have your protocols executed and fully documented by Körber experts to ensure compliance and accuracy.

Capabilities

A rigorous path to compliance

Navigate machine qualification with a structured process designed to ensure regulatory readiness and operational success.

Global compliance expertise 

Our services ensure full compliance with GMP, GAMP, Annex 11, and Annex 15 standards. We provide clear and auditable documentation from initial protocol creation to final summary reports. By integrating risk management throughout the process knowledge and design phases, we reduce deviation rates and provide stable system operation under qualified conditions.

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Get in touch

Speak to our specialists about our range of flexible, scalable, end-to-end solutions—tailored to you.