Engineering Services
Life science Engineering Services
Engineering Compliance -Harmonization of Project Management and Quality Assurance
● Engineering Compliance Management ensures, GMP*, GEP* and Client-specific project execution requirements (e.g. Process , HSE)
● Project Management defines itself as the management of time, cost, quality compliant project delivery.
● Engineering Compliance supports directly the Project Management to ensure project quality and indirectly time- and cost efficiency.
Engineering Compliance covers the planning, coordination and control of the following project activities :
Project Baseline
● Development of documentation concept
● Development of commissioning concepts
● Safety analyses and safety assessments for plants that are subject to accident prevention regulations.
● Development of qualification concepts
● Development of leveraging concepts
● Development of training concepts
GMP Compliance
● Development of qualification master plans
● Development of (GMP-) risk analysis
● Development of qualification plans
● Development of test specifications
● Change- and Deviation Management
● Documentation Management
GMP Compliance
● Ensurance of phase gate project execution and documentation (user requirements – design – construction – commissioning)
● Execution of design reviews
● Coordination of FAT/SAT activities
● GMP-compliant inclusion of supplier activities and documentation within project execution (commissioning & qualification – leveraging)
● Ensurance of client specific requirements, regulations and processes à roll-out to 3rd party project participants such as contractors, suppliers etc.
Engineering Compliance - Integration and interaction with project team
| Engineering Phase | Engineering Activity | Compliance Activity |
|---|---|---|
| Concept-/Basic Engineering | User Requirements; PFDs User Requirements; PFDs Layout studies; Equipment List User Requirements; PFDs Layout studies; Equipment Lists |
Documentation - Commissioning, Qualification, and Training Concepts Risk Analysis; Training Execution |
| Detail Engineering Start Qualification |
P&Ids; Specifications; Tendering DQ; Expediting, FAT |
Design Reviews; Change Management Deviation-Management; Trainings |
| Installation & Commissioning | Installation-co-ordination Installation and Functional Testing |
Reviews & Releases; Change Management Deviation Management; Trainings |
| Final Qualification | IQ/OQ/PQ | Reviews & Releases Change-Management Deviation-Management Trainings |
