GMPSysteme

GMPSysteme is a software and services company focused on enabling Good Manufacturing Practice (GMP) compliance for life sciences manufacturers. Its core offering is an electronic quality management system (eQMS) that supports documentation, deviation and CAPA management, change control, training, audit management, and supplier qualification. The platform can integrate with manufacturing execution systems (MES) and laboratory information management systems (LIMS) to ensure data integrity across the product lifecycle.

Regulatory alignment is central to GMPSysteme’s approach. It emphasizes electronic records and signatures, audit trails, and access controls to meet standards such as FDA 21 CFR Part 11 and EU GMP Annex 11.

Services include implementation, validation, data migration, system integration, training, and ongoing compliance support, with advisory offerings to help customers prepare for inspections and maintain GMP readiness.

Markets and customers include pharmaceutical, biopharmaceutical, contract manufacturers, and medical device companies seeking standardized quality processes, reduced cycle times, and consistent cross-site compliance. The company maintains partnerships with ERP, MES, and automation vendors to enable integrated GMP information flows.

GMPSysteme operates internationally and serves clients across Europe, North America, and other regions in regulated industries.