Integration of mechanical, software and electronic systems technologies for vehicle systems了解行业应用
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assets了解行业应用
Integration of manufacturing process planning with design and engineering for today’s machine complexity了解行业应用
Insurance & Financial
Visibility, compliance and accountability for insurance and financial industriesExplore Industry
Media & Telecommunications
Siemens PLM Software, a leader in media and telecommunications software, delivers digital solutions for cutting-edge technology supporting complex products in a rapidly changing market.Explore Industry
Faster time to market, fewer errors for Software DevelopmentExplore Industry
Small & Medium Business
Remove barriers and grow while maintaining your bottom line. We’re democratizing the most robust digital twins for your small and medium businesses.Explore Industry
Siemens Digital Industries Software Regulatory Compliance
The core mandate that guides FDA regulatory oversight is consumer safety. As a result, the FDA has defined current Good Manufacturing Practices for both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to consistently produce quality products.
The goal of meeting the challenge of manufacturing regulatory compliance is the establishment of a consistent “top down” strategy for ensuring compliance across the manufacturing enterprise. Camstar has responded to this need by creating computer software for manufacturing regulatory compliance – Enterprise Manufacturing Execution Systems that satisfy the needs of Medical Device and Biotechnology manufacturers for a comprehensive compliance solution.
Fully 21 CFR Part 11 compliant, Camstar’s Manufacturing Execution and Quality System provides the comprehensive enterprise technology infrastructure manufacturers need to maintain regulatory compliance while dramatically reducing its associated costs and risks. Camstar enables manufacturing business process automation by creating a paperless manufacturing environment for the establishment, maintenance and management of regulatory compliant global manufacturing operations. Camstar allows companies to more easily and cost-effectively maintain compliance with good manufacturing practices.
Camstar’s Enterprise Platform for Advancing Product Quality helps global manufacturers deliver the highest quality products, on time, the first time, every time. By enabling real-time, enterprise visibility, enforcing manufacturing controls and feedback into product design, global compliance is a natural outcome.
Camstar’s Platform drives global risk-based compliance management by enabling operational excellence and making compliance with international regulatory and industry standards a natural by-product of efficient, high quality processes.