We competently support You in the realization of Your technical projects. For You we develop optimal, time and cost efficient solutions, always keeping in view the GMP compliance and the realities of Your process flow. From the definition of specifications in accordance with regulatory demands (e.g. User Requirement Specifications), over procurement and project supervision, through to equipment qualification and commissioning: We advise and support You on all aspects and questions.
In all this, we stand at Your side and keep our professional independence from any technical supplier.
Our services at a glance:
- Preparation of construction concepts for new facilities (e.g. media systems and clean rooms)
- Preparation of User Requirement Specifications (URS), specification requirements and functional specifications
- Assistance with preparation of advertising for project procurement, advising support in the commissioning of a project procurer
- Advising support for the design of GMP conforming installation concepts and of individualized technical solutions
- Preparation of all risk analyses required (e.g. according FMEA standard)
- Monitoring of project progress
- Performance and / or supervision of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
- Support in qualification, validation and commissioning of equipment
- Equipment calibration
- Revision and update of technical equipment documentation