• VTU Engineering provides Computer System Validation (CSV) services for the highly regulated pharmaceutical and medical technology sectors. We assist you in implementing and maintaining the compliance of your computer systems.

 

  • As an interface, we act as a point of contact for various departments, including automation, production, and IT.

 

  • Our expertise includes, but is not limited to, creating validation documents such as User Requirement Specifications (URS)Failure Mode and Effects Analysis (FMEA), validation plans, and reports. We also review test reports and standard operating procedures (SOPs).

 

  • We ensure the data integrity of systems and operate in accordance with current Good Manufacturing Practice (GMP) guidelines, particularly the EU GMP Annex 11 and 21 CFR Part 11 - Electronic Records and Electronic Signatures (ERES).

 

  • Our team-oriented professionals with strong engineering, computer science, or science backgrounds facilitate effective communication across departmental boundaries.

 

 

Want to know more about our services or have a question? Write to us at csv@vtu.com

 

Arrange an expert consultation now

Herbert Andert

Division Manager Automation & Industrial Digitalisation
Kontaktieren

Elke Wieser

Team Lead CSV
Kontaktieren