PQMC - Company Profile


From years of experience in industry & consulting I would like to offer you services in the following areas of competence:

  • Validation of Computer-Systems (Standalone-PC to IT-Infrastructure) and Computerised Systems (e.g. Machine Controller)
  • Supply Chain & Storage-Validation
  • Compliance Inspections (Audit-preparation, GxP-Trainings)
  • Quality-Management (regarding regulations like FDA 21 CFR, ISO-standards, a.o.)
  • Product-Selection and Implementation (LIMS, ERP, DMS…)
  • Regulatory Affairs (Submission Documentation for Pharmaceticals and Dietary Foods)
  • Projectmanagement

If you need Quality Documentation I am at your service with:

  • Quality Manual
  • Standard Operating Procedures (SOPs)
  • Validation Masterplan (VMP)
  • Validation-Plan
  • User Requirements Specifications (URS)
  • Functional Spezifications (FS)
  • Design Spezifications (DS)
  • Design Qualification (DQ)
  • Qualification Plans and Execution (IQ, OQ und PQ)
  • Validation Report

If you have questions regarding services not listed above, I will be happy to answer your request!

Qualität ist das Produkt der Liebe zum Detail!