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  Specialists for highly regulated industry

The services provided by Chemgineering have developed during years of experience gathered in a constantly changing and highly regulated industry. In this field, our service performance covers the complete lifecycle of pharmaceutical products - starting with the investment initiation continuing through production and qualification right up to maintenance management in daily operation. Illustrated by simulation models, our analyses of production and business processes serve as the basis for determining user requirements, risk management and other management decisions.

GxP-compliance is an important focus of Chemgineering. Information systems have become indispensable key elements of economic GxP-compliant processes. We have therefore specialised in the validation of ERP and process control systems as well as of laboratory instruments. We are recognised experts in the practical adherence to the regulations concerning the electronic signature according to 21 CFR part 11.

Our services

Business Process and Risk Management
Production Optimization
Site Master Planning
Technology Transfer
Process Analysis/
URS Development
Document Management Systems
Archiving Systems
Maintenance Management Systems
Calibration Management Systems
Simulation Logistics
Production Processes
Supply Chain Management
Risk Analysis HAZOP
FMEA
GxP
Project Risk (Time and Cost)
Investment Initiation
Concept Finding (ICD) Fermentation
Downstream Processing
Blood Derived Products
Solida Production
API's
Highly Potent Drugs
Sterile Filling
GLP Laboratories
Logistics
Quality and GxP Compliance
cGMP Finding (ICD) Zoning Concepts
Cleaning Concepts incl. CIP
Sanitisation/Sterilisation Concepts
IS in Pharmacovigilance
IS in GMP Maintenance
Quality Systems
GMP Change Control
IS in Regulatory Affairs
Variants Analysis
Critical Systems
Start- Up Consulting
Qualification/Validation Validation Concepts CSV
MVP CSV
IQ Protocols and Execution CSV
OQ Protocols and Execution CSV
SAP CSV (Planning)
SAP Protocols and Execution
Qualification/Validation Concepts
 (non IS)
IQ Protocols and Execution
OQ Protocols and Execution
PQ Protocols and Execution
Cleaning Validation (Planning)
Cleaning Validation Protocols and
 Execution
Process Validation Planning
Process Validation Execution
SOP's SOP Structures CSV
SOP Structures Non-CSV
SOP Development CSV
SOP Development Non-CSV
Quality Audits/Mock Inspections In-house
Suppliers
GAP Analysis Part 11
cGxP
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