Impressum  
     
 

Click on the following links for detailed information on selected projects:

Computer System Validation (CSV) for pharmaceutical production process

GxP-conforming quality management system for major hospital pharmacy

21 CFP Part 11 Compliance Pharma laboratory systems for production and analysis

21 CFP Part 11 Compliance consolidation

SIP – Strategic Information Planning and Personnel Management

Click here for a detailed summary of our projects.

 

   
  GxP-conforming Quality Management System for a major Hospital Pharmacy
Goal
Development and implementation of a full range QM-system for a major hospital pharmacy (distribution and production of sterile and non-sterile drugs) in order to receive wholesale and production permission from the inspecting authorities.
Method
GxP audit; analysis and concept development; structuring, preparation, training and implementation of the required QM-documentation; planning and process support for qualifications/validations; preparation and support for inspections.
Result
Fully established QM-system, two successful official inspections and granting of required permissions for the production and distribution of drugs.
Duration

1.5 years