Opcenter Execution Medical Device and Diagnostics provides MES functionality, including electronic device history records (eDHR), for medical manufacturing.
Opcenter Execution Medical Device and Diagnostics (MD&D) helps medical device manufacturers by contributing to productivity, product quality and speed to market.
Error-proof manufacturing processes
Leverage Opcenter Execution MD&D system's intelligent data analytics to gain manufacturing insights that lead to quality and cost improvements. Our medtech MES solution standardizes data from the shop floor and digitally captures manufacturing know-how, enabling your company to shift from managing documents (often still paper-based) to managing enterprise-wide metrics.
Implement paperless manufacturing
Increase quality, efficiency and time to delivery with Opcenter Execution MD&D system's great flexibility and streamlined integration of product design, engineering and manufacturing. Our medtech manufacturing execution system (MES) decreases the likelihood of product delays, unforeseen errors and field failures – especially for new product introductions (NPIs).
Use self-auditing eDHRs and eBRs
Deliver regulatory compliance automatically and with reliable accuracy. Opcenter Execution MD&D automatically generates electronic device history records (eDHR) and electronic batch records (eBR), enforcing production processes and capturing all information associated with as-built production records. Self-auditing eDHRs and eBRs perform error-proofing and provide real-time visibility to produce consistent product quality.
Manage good manufacturing practices and regulatory compliance
Meet the challenges of ever-changing regulations and standards with a medtech MES that keeps up. The European Union's regulations for medical devices (EU MDR) and the United States' Food and Drug Administration (FDA) Case for Quality program are spearheading a worldwide transformation of MD&D regulations and good manufacturing practices. The paperless manufacturing and documentation in our solution makes your compliance easier.
Accelerate configuration and change management
Quickly adapt to changes unique to the MD&D industry, including the internet of medical things (IoMT), personalized medicine, value-based care and real-world evidence models. Innovate confidently for timely NPI such as connected devices, wearable technologies and devices-as-a-service. Opcenter Execution MD&D supports rapid production changeovers for complex products and smaller batch or lot sizes.
Odvětví:Lékárenství a farmaceutický průmysl
Umístění:Somerset, New Jersey, United States
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