Implementation

VTU is a planner and consultant for the pharmaceuticals, life science and medical technology industries. A key focus of our activities lies in the provision of GMP services with regards to the qualification and validation of plants, processes, computer systems and medical devices. What’s more, we offer consulting services when it comes to introducing GMP-compliant processes in engineering, production, the laboratory and quality assurance - all the way to assistance with audits and inspections.

The experts at VTU Engineering bring with them comprehensive experience across a wide range of different products and are well aware of the industry requirements through their work and regular training in the fields of GMP and pharmaceuticals. Similarly, you can also profit from the high level of our technical and organizational competences. VTU has been carrying out risk analyses internally and in customer projects, both in the field of GMP and in the field of security technology, for years. In doing so, the risk analysis experts at VTU often take over the moderation of risk analyses.

We are also happy to support you when it comes to introducing this software in your company. We work together with you to define your risk management process and help to implement this into the software system.

System architecture and licenses

REXS is implemented as a server/client application with a SQL server for data management. The necessary hardware / software (e.g. client computers, servers, operating systems, SW licenses for SQL server etc.) is provided by the licensee. REXS works with the concurrent user license model.

Implementation and training

We are happy to support you with the database installation and, if required, offer additional REXS training as well as training and consulting regarding the structuring and implementation of risk management processes.

Maintenance and support

REXS support, service, maintenance and support services are included in the purchase price for one year from the date of purchase. After that, you have the option to sign a maintenance contract. Maintenance, service and support are performed by our REXS - team in Austria.

Validation

The REXS software is classified by VTU as software category 3 according to GAMP 5 (Good Automated Manufacturing Practice Guide).

The following validation documentation can be delivered as standard: URS, risk analysis, FAT or SAT plan and report.
We are also happy to check and offer customer-specific requirements for the validation of REXS with regard to feasibility.