Machine qualification

Keep patients safe and your production on track with reliable, compliant, lifecycle-long machine qualification.

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Choose an expert partner in equipment and qualification to guarantee a faster track to production.

Patients depend on reliable, validated equipment, while manufacturers face increasing pressure to reduce time-to-market. Our combined Machine qualification addresses both needs by combining speed with compliance through structured qualification and risk-based testing.

Benefits

30% faster machine qualification

Increase machine qualification up to 30% through optimized setup and guided qualification workflows.

Risk-free qualification

Qualify your machines quickly while staying fully compliant, reducing regulatory risk and avoiding delays. 

Stay compliant with global standards

Maintain compliance with EU GMP Annex 15 and ASTM E2500 standards and ensure your qualification meets regulatory expectations.

Less downtime

Reduce disruption during qualification and resolve issues faster, helping you start production.

Consistent quality from day one

Align URS, risk assessment, and test strategy early with our specialists to ensure efficient qualification from the start and avoid delays. 

Shorter time-to-market

Achieve a fully validated, production-ready machine faster, helping you move efficiently into operations. 

Align teams and improve collaboration

Keep machine experts, project management, and quality teams working in sync to avoid misalignment and rework. 

Our approach

End-to-end qualification planning

Körber’s machine qualification approach connects every stage of your equipment lifecycle, helping you move from design to validated production with less risk and fewer delays. 

Downloads

Documentation

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Brochure: Visual Inspection Qualification Services

Learn how you can enhance compliance and confidence with expert‑led visual inspection qualification services.

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Flyer: Accelerate machine qualification 

Learn the core principles and best practices for machine qualification to ensure reliable performance, compliance, and quality in pharmaceutical production environments.

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Brochure: Agile Machine Qualification 

Learn how Körber’s Agile Machine Qualification methodology accelerates machinery integration and shortens time-to-market.

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Validation

We provide expert consulting services to support the validation and qualification of your equipment, software, and processes according to regulatory standards.

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Get in touch

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