Safety System Implementation for Pharmaceutical Companies
Implementing a reliable safety system requires more than just software — it needs a customized IT infrastructure that combines efficiency, scalability, and regulatory compliance. We provide comprehensive support from planning to successful implementation.
IT Infrastructure & Hardware Consulting
A stable and secure IT infrastructure is the foundation of a high-performing safety system. We offer expert advice on optimal hardware architecture, scalability, and high availability to ensure smooth performance and long-term operational reliability.
Software Integration & Compatibility Testing
We ensure that your safety software is seamlessly integrated into your existing IT landscape. Our experts assess the compatibility of all software components, optimize interfaces, and ensure that your system runs efficiently and stably.
GxP-Compliant Software Validation
Regulatory frameworks such as GxP, FDA 21 CFR Part 11, and EU-GMP Annex 11 require precise validation. We guide you through the entire validation process — from requirements analysis to test protocols and final approval, ensuring full compliance and audit readiness.
Specialized in Oracle Argus Safety & Axway B2BI
As specialists in Oracle Argus Safety, we support pharmaceutical companies in efficiently managing adverse event reporting and complying with global regulatory requirements. We also offer Axway B2BI integration for secure and seamless data exchange between stakeholders and regulatory authorities — ensuring smooth and compliant communication.
Your Partner for a Future-Proof Safety System
With our experience in IT infrastructure, software consulting, and validation, we ensure that your safety system meets not only today’s demands but is also ready for the future. We support you with strategic consulting, technical implementation, and long-term support so your systems remain reliable, compliant, and high-performing.