Software for GMP Environments
Quality assurance plays a key role in the production of pharmaceutical products and active agents, as well as in the production of cosmetics, food products and animal feeds. In this GMP-regulated setting, software is increasingly becoming a key component in the management of machines and equipment and in assisting with operating processes. It therefore needs to meet clear legal and normative guidelines.
As a long-term development partner for medical and IVD products, infoteam has a certified quality management system according ISO 13485. With this, in addition to MDR and IVDR, we also cover the key requirements of FDA 21 CFR Part 11 and Part 820 (QSR) as well as EU-GMP Annex 11 and Annex 15, in particular risk management, change management, requirements traceability, software lifecycle model and documentation for approval procedures.
Our developers are also trained accordingly and are experienced in software development in a strictly, normatively regulated environment. We can therefore guarantee efficient software development in collaboration with you, even in the case of complex conditions for individual projects (e.g. for GAMP 5 development with additional product and industry-specific requirements).