Computer System Validation Services

urthermore, we can support you in setting up your CSV strategy and questions in the area of data integrity within your company. Due to the close interlinking of the automation, MES, compliance and electrical engineering departments with the CSV within the VTU, all phases and processes within a project can be optimally covered. 

The pharmaceutical industry is a highly regulated area. Quality management is essential in the pharmaceutical industry. It must be ensured that the end product is safe for the end user. CSV is part of these compliance requirements. Computer systems play a central role in the manufacture and testing of drugs in the regulated pharmaceutical sector. This also explains why those systems have to be validated under GMP conditions. The purpose of a validation process is to ensure that a computer-based system is doing exactly what it is supposed to do in a consistent and reproducible manner.

The integration of the CSV in the regulated area depends on the type of system to be validated as well as the degree of automation. 

• Validation of new or to be updated ERP (SAP, Sage etc.), MES (AVEVA, Werum, Emerson Syncade, etc.) and PLS / DCS systems (DeltaV, SIMATIC PCS7, APROL ...)
• Control qualification of packages
• Support in setting up the SOP landscape for CSV in your company
• Contact person for questions about data integrity
• Validation of computerized laboratory equipment
• Support with 21 CFR Part 11 (ERES - Electronic Records & Electronic Signatures) and EU Annex 11 in handling data