Engineering & Validation Services

You have to realize an ambitious investment project.

  • You have to increase your staff to achieve a given timeline.

  • You now need external assistance in pharmaceutical engineering and/or validation services.

You get award of the contract for an ambitious investment project.

  • You hold excellent capacity utilization and now you need rapid external assistance in project management, technical documentation and/or validation services in customers order.

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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.

Im 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

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