REXS is an innovative software system for the efficient creation of risk analyzes and the central management of measures. The software enables the use of different methods such as FMEA, HAZOP, Ishikawa diagrams or user-defined methods and is the perfect moderation and documentation tool for carrying out risk analyzes. In REXS, the regulatory requirements for lifecycle-oriented risk management (eg according to ICH Q9 or EN ISO 14971) have been put into practice. Risk communication can be in REXS - by reusing knowledge at the touch of a button - easy to implement.

Risk management simple and GMP compliant

• Custom configuration (for example, forms, rating catalogs, and risk matrices)
• Combination of tabular / graphical methods
• Automatically generated action catalogs for status and appointment tracking for each risk analysis document / project phase
• GMP-compliant document creation
• Document sharing via the integrated commenting process by authorized persons
• Data output in popular formats such as PDF, RTF (Word) and Excel
• Creation of standardized risk analyzes in your company-specific document layouts

Risk analyzes are created on the one hand by different people and on the other hand in a time-very large distance. The resulting knowledge and information gaps in the Risk management process can be avoided by REXS. REXS is a client-server application and can be used across departments and locations to optimize the risk management process across the enterprise. The data entered when creating a risk analysis in the REXS database is linked via a logical network and the users in all further risk analyzes and Evaluations provided. Actions can be managed easily and centrally in the system. Already developed knowledge is thus not lost, but is still available company-wide, well structured and available at any time.

• Location-independent management and reuse of risk knowledge
• Central management of all documents related to the risk management process in the integrated Explorer
• Action module for the central administration and follow-up of all measures to be carried out
• Bring the right information to the right people and at all times
• Import / export functions for risk analysis
• Comprehensive search functions - you can even find risks that you have already considered.
• Fast system introduction and user acceptance through intuitive user interfaces

REXS - by experts for experts

REXS is based on the many years of experience of the VTU experts in the GMP and security sector. The system supports the experts in the pharmaceutical, medical and engineering sectors who implement an FDA and EU GMP-compliant risk management process.

• Development and validation according to Annex 11 of the EU GMP Guide, 21CFR11 and GAMP 5.0
• GMP-compliant risk analysis documents can be created in a version-managed manner, checked by authorized persons and released and archived unalterably.
• Lifecycle-oriented risk management, e.g. according to ICH Q9 and EN ISO 14971

We support you in introducing the software in your company. Together with you, we define your risk management process and help you to implement it in the software system.

Company profile
VTU Engineering is a planner and consultant for the pharmaceutical, life science and medical technology industries. One focus of our activities is on GMP services in the qualification and validation of plants, processes, computer systems and medical devices.
In addition, we offer consulting in the introduction of GMP-compliant processes in engineering, production, laboratory and quality assurance to cooperation in audits and inspections. The experts at VTU Engineering have extensive experience in a variety of different projects and know the requirements of the industry by working and continuous training in the areas of GMP and Pharma. You can equally benefit from the high level of our technical and organizational skills.
VTU has been carrying out risk analyzes in-house for years and in customer projects both in the GMP area and in safety technology. The risk analysis experts often take over the moderation of the risk analyzes. In order to implement lifecycle-oriented quality risk management, the model of object-oriented risk management was developed by VTU in cooperation with gempex, which should support companies in introducing and optimizing their risk processes. The REXS software was developed on the basis of our many years of experience in the areas of security, GMP, risk and quality management.