eValidation

Replace manual, paper-based validation with structured workflows, automated documentation, and real-time traceability.

a Körber employee in a lab environment dressed in safety gear

Transform validation from a bottleneck into an enabler with our end-to-end approach

Our digital, automated, and GMP-compliant validation approach accelerates lifecycle processes, ensures data integrity, and enables continuous audit readiness for pharma and biotech.

Benefits

Faster, more predictable cycles

Digital streamlined workflows with predefined templates reduce human error during execution of IQ/OQ/PQ and enable harmonization of validation documentation.

Full compliance and data integrity

Automated audit trails and automated real-time traceability ensure ALCOA+ data integrity, drastically reducing preparation time for inspections. 

Global regulatory expertise

Our solution follows GAMP 5 best practices and aligns with key regulatory standards, including Annex 11, and 21 CFR Part 11.

Scalable and collaborative

Global teams can operate from a unified environment where reviews and approvals are standardized, making cross collaboration easier.

Reduced risks

Thanks to controlled workflows and automated checks, you can reduce errors and strengthen compliance across all validation activities.

Simple integration into existing systems

eValidation integrates naturally into existing MES, LIMS, QMS, and DMS environments, ensuring an easy setup.

a Körber employee in a lab environment

End-to-end ecosystem

Validation across the entire lifecycle

 eValidation supports the full computerized system validation lifecycle – from user requirements specification through installation, operational, and performance qualification, to ongoing monitoring and change management.

Digital workflows, structured test protocols, and automated documentation ensure consistency and automated traceability at every stage. 

The solution integrates into existing MES, LIMS, QMS, and document management systems, enabling seamless alignment with regulated manufacturing environments.

By standardizing templates, workflows, and approvals, eValidation reduces complexity, improves collaboration across global teams, and enables better decision-making through real-time data and dashboards.  

Why Körber

In numbers

50%

Automation and standardized templates lead to a 50% reduction in overall cycle times for pharmaceutical and biotech manufacturers.

85%

Digital workflows and automated activities reduce up to 85% of the effort to create validation documentation, when compared to manual, paper-heavy processes.

Case study

Downloads

Download icon in a blue background

Integrated manufacturing with Körber’s software solutions 

Novo Nordisk accelerates medicine delivery with PAS-X MES in the cloud

Download file
Körber employee smiling

Get in touch

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