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!