Business Areas

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
Installation & Commissioning Installation-co-ordination
Installation and Functional Testing
Reviews & Releases; Change
Deviation Management;
Final Qualification IQ/OQ/PQ Reviews & Releases