Use our many years of CSV experience to successfully implement your software projects in the regulated GxP area and maintain the validated state.
Furthermore, we can support you in setting up your CSV strategy and with data integrity issues within your company. Due to the close integration of the automation, MES, compliance and electrical engineering departments with CSV within VTU, all phases and processes within a project can be covered optimally.
The pharmaceutical industry is a highly regulated sector. Quality management is essential in the pharmaceutical industry. It must be ensured that the final product is safe for the end user. CSV is part of these compliance requirements. Computer systems play a central role in the production and testing of medicinal products in the regulated pharmaceutical sector. This also explains why those systems must be validated under GMP conditions. The purpose of a validation process is to ensure that a computer-based system does exactly what it is supposed to do in a consistent and reproducible manner.
The integration of CSV in the regulated area depends on the type of system to be validated as well as the degree of automation.
- Validation of new ERP (SAP, Sage etc.), MES (AVEVA, Werum, Emerson Syncade, etc.) and PLS-/DCS systems (DeltaV, SIMATIC PCS7, APROL …) or systems to be updated
- Control system qualification of packages
- Support in setting up the SOP landscape for CSV in your company
- Contact for data integrity issues
- Validation of computerised laboratory equipment
- Support for 21 CFR Part 11 (ERES – Electronic Records & Electronic Signatures) and EU Annex 11 in handling data