Quality Engineering

Quality Engineering

Through our Quality Engineering services we can support the full life cycle of your facilities. From concept phase through design and construction until commissioning, our consultants offer you a risk-based approach to build or revise GMP compliant facilities. Our consultants will demonstrate compliance throughout each project phase, including retirement and decommissioning.

Design Concept

Co-write the User Requirement Specifications in cooperation with the business partners (users)
Develop proces flow diagrams
Create facility layouts and PI&D's
Draw up personnel and material and waste flow diagrams
Create and maintain equipment and utility requirements.
Project planning and cost budget estimation

Basic Engineering

Create contracts (SLA) for vendors and suppliers based on the design concept
Perform Impact Assessment (Direct or In-direct Impact)
Perform Critically Assessment
Develop the project validation plan (VMP en SMP)
Write Functional design specifications, P&ID's, Cleanroom and equipment specifications etc.

Procurement and Construction

Support purchasing equipment and services
Review vendor/supplier documentation (FAT and SAT)
Manage, supervise and inspect construction activities
Monitor project progress (ensure compliance during project)

Commissioning, Qualification and Validation

Quality is integrated from the earliest stages of the project
Through FAT and SAT to commissioning

Qualification by IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification)

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