Transform your compliance challenges under a regulated environment into a business advantage with MasterControl!
MasterControl is a global standard for integrated QMS software, boasting numerous implementations worldwide, including with the FDA (U.S. Food and Drug Administration). It has garnered significant support in heavily regulated industries such as pharmaceuticals and medical devices. By leveraging the global market experience we have accumulated, we will build a QMS that benefits your business. As a user-oriented system integrator responsible for the IT transformation that supports the global strategy and operations of the Fujifilm Group, we contribute to solving various challenges faced by our customers based on our extensive experience and track record. 【Free Webinar on 9/4! Learning from Administrative Inspection Cases on QMS System Utilization】 For more details, click here → https://www.fujifilm.com/fbds/news/20250805
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【Supporting the optimal design and accurate execution of quality assurance operations】 By visualizing and organizing complex business processes, we can stably operate the PDCA cycle of quality management. Our solution leverages extensive experience in the medical device industry to assist in designing optimal business processes, while also utilizing MasterControl to digitize processes, thereby strongly supporting smooth operations. This enables the accurate and thorough execution of daily tasks such as document version control, change management, planning and management of training, and management of quality events such as complaints. 【With abundant best practices, we ensure thorough audit preparation and regulatory compliance】 Through extensive implementation experience in the life sciences industry, we have accumulated numerous best practices. We provide a variety of templates and frameworks that comply with domestic regulations and ISO standards, as well as international standards such as FDA, ICH, and IMDRF, alleviating concerns regarding inspections, audits, and compliance.
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Adopted by the FDA (U.S. Food and Drug Administration)! This solution is implemented by over 1,000 other companies.
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Pacific Business Consulting has been supporting the promotion of DX by utilizing technology for group affiliates and many customers. We provide the know-how cultivated through that experience to our customers through various solutions and services.
