TRIPLAN India Pvt. Ltd. Pune
TRIPLAN INDIA PVT. LTD.
Engineering Consulting Services Digital Factory Design Engineering Services Pune

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)

Engineering Consultancy Services
Life science Engineering Services
Life Science Sector
• 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
• Development of qualification concepts
• Development of leveraging concepts
• Development of training concepts

Engineering Services

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

GEP-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
 
For More Details   • Send Enquiry
 


Engineering Compliance for     GMP
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