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.

 

   
  21 CFR Part 11 Compliance Consolidation
Goal
Consolidating all projects and activities of a global pharmaceutical company and setting global standards for 21 CFR Part 11.
Method
Definition and development of a system to register centrally all global activities relating to 21 CFR Part 11 compliance and evaluate the current status. Management of global activities in order to develop globally a consolidated system family during the course of the project.
Result
Consolidation 21 CFR Part 11 compliance for all systems.
Duration

1 year