With the design and advice of solutions international standards are used as much as possible recognized. From a technical view, these are the ISA standards (ISA-18, ISA-88, ISA-95, ISA-99 and ISA 100, ISA-106). Projects are mainly structured according to GAMP 5 and Prince 2. Elements of Six Sigma and Lean Manufacturing are always included.
An important principle is that a system the user gets what he wants, even though he himself does not know what he wants. It is my task to capture and translate wishes and demands of the users into requirements that suppliers do understand and deliver. A Risk based "approach, where all requirements are traceable and maintainable during and after the project, is applied.
Services that this can be delivered are:
With Annex 1 paper in not to be used in clean rooms anymore, In a recent project, where I was responsible for the design and implementation of the automation, paperless production was created compliant to EU GMP and FDA regulations.