Engineering & Validation Services

My offer at my earliest convenience:

• You may be sure; I understand the engineering behind your running process, so I can quickly respond to your specific needs.
• My work is conducted in strict accordance with GMPs and with your quality requirements.
• I provide solutions staying abreast of current regulations and industry practices.

Your procurement guidelines require registered contractors? No problem!

• I can colloborate as sub-contractor with your favored engineering company.

I´m competent to support your:

• concept engineering and supplier selection
• detail engineering and design review
• mechanical compilation and start-up including FAT / SAT

I can develop and audit your

• Validation Master Plans
• User- and Functional Requirements Specifications
• Risk Assessments
• Protocols for commissioning including Factory- and Site Acceptance Tests
• Protocols for Design-, Installation- and Operational Qualifications
• Protocols for Performance Qualifications

I create and verify your documents

• as thoroughly as necessary,
• according to form and regulations,
• as fast as possible.

My offer to support your project management at my earliest convenience:

• I examine and handle specification documents, you receive - as requests - from your customers.
• I collect and review customer demands in touch with your engineering department.
• I generate your project planning, assume project controls and arrange meetings, FAT and SAT.

Supporting documentation & validation: I create the requested specification documents, you will send - as intended solutions - to your customers e.g.

• Functional Requirements Specifications
• Risk Assessments
• Commissioning protocols including Factory- and Site Acceptance Tests
• Qualification-Protocols