Seamless Consulting Services

Achieve audit-ready compliance and a reliable start of production with integrated consulting that aligns your Standard Operating Procedures, User Requirements Specifications, and qualification directly with your machinery project.

a Körber employee presenting a white board to a group of people

Execute efficient machinery projects with a structured, execution-ready foundation that reduces rework and shortens iteration cycles.


Benefits

One integrated approach

Align documentation, requirements, and qualification around your machinery project to avoid gaps, reduce rework, and ensure seamless execution.

GMP-compliant foundations

Define and document Standard Operating Procedures, User Requirements Specifications, and qualification plans from the start for audit‑ready execution that meets strict pharmaceutical regulations.

Faster and predictable readiness

Coordinated quality planning and efficient IQ/OQ/PQ execution shorten iteration cycles to support an on-schedule production start.

Scalable consulting modules for every project phase

Whether you are defining initial requirements or executing final performance tests, our consulting services are modular. You can select specific support for a single machine or implement an integrated package to manage your entire quality and documentation landscape from start to finish.

  • a Körber employee in a lab environment

    User Requirements (URS) and Standard Operating Procedures (SOP)

    Define technical requirements and establish GMP-compliant workflows with structured User Requirement Specifications and custom SOP landscapes.

  • a Körber employee in a lab environment working on software

    Quality project plan

    Structure your project scope, roles, and risk evaluations based on your Validation Master Plan to ensure predictable, audit-ready execution.

  • two Körber employees in a lab environment

    IQ/OQ and PQ Execution / support 

    Qualify machines efficiently with professional protocol creation and testing that confirms capability under real operating conditions.

Compare

Our consulting variants

Each module is designed to solve specific compliance and engineering challenges. Use the table below to compare the focus and primary deliverables of our core consulting variants. 

Feature 

SOP Management 

URS Creation 

Quality Project Plan 

Qualification (IQ/OQ/PQ) 

Primary focus 

Workflow definition 

Requirement setting 

Project governance 

Machine qualification 

Deliverable 

Approved SOPs 

URS Document 

Approved QPP 

Test Reports 

GMP goal 

Process consistency 

Technical priority 

Risk management 

Proven capability 

Typical effort 

~7 days per SOP 

1–4 weeks 

2 months – 2 years 

Project dependent 

Case studies

Learn how our solutions work in the real world.

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Get in touch

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