Qualification and Validation Services for Production Processes and Complete Production Sites - Front-End-Engineering services for GMP regulated industries

01.08.2012

Qualification of laboratory and production equipment, utilities such as WFI, AP and process steam, maintening of the clean room conditions or assistance in computer validation.

We offer qualification and validation services, individually or as part of a complete engineering project:
  • Development of qualification and validation strategies
  • Development and compilation of master documents (Validation Master Plan, Qualification Master Plan, Quality Assurance and Project Plan)
  • Development and compilation of risk analysis documents based on established methods (FMEA, FTA, HACCP)
  • Compilation of qualification plans (DQ/IQ/OQ/PQ)
  • Compilation of qualification reports (DQ/IQ/OQ/PQ)
  • Conducting of qualification tests 
  • Consulting on the implementation of process and cleaning validation
 
Further services:
  • Preparation, implementation and protocolling/documentating of factory/site acceptance tests (FAT and SAT)
  • GMP-Compliance training of clients personnel
  • Auditing of companies (supplier audits, supplier qualifications)
  • Document management according to clients requirements
  • Supplementary training offers for qualification, process and cleaning validation