Pharmaceuticals

Data integrity support for Rigaku products

For pharmaceutical companies, GMP compliance is an essential element in balancing quality assurance and regulatory adherence. Rigaku provides systems compliant with international regulations such as FDA 21 CFR Part 11 and EU-GMP Annex 11, creating an environment where users can operate with confidence. Our proprietary SureDI library, developed from the “ER/ES System & Audit Trail” of our X-ray diffraction systems, goes beyond electronic records and electronic signatures to include comprehensive user management, audit trails, and data integrity. This functionality has also been extended to Rigaku’s thermal analysis instruments and energy-dispersive X-ray fluorescence spectrometers, enabling regulatory compliance across three analytical technologies. As a result, quality control departments can ensure compliance while the production floor benefits from efficient and reliable data management. Rigaku’s systems are a secure choice for managers and decision-makers, and a practical partner for operators in daily workflows.