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Siemens Opcenter for Paperless Medical Device Manufacturing
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Combining the challenges of traditional discrete manufacturing with a high level of regulatory control, medical device manufacturing presents a unique set of business obstacles. To remain competitive, manufacturers must execute production efficiently, manage operational costs and ensure regulatory compliance while consistently producing high-quality products.
To address these challenges, IndX leverages Siemens Opcenter Execution Medical Device and Diagnostics, formerly known as the Camstar Medical Device Suite. As part of a Manufacturing Execution System offering, Opcenter Execution Medical Device and Diagnostics was designed to enforce control across the five Ms of manufacturing: Man, Machine, Method, Material and Measurement.
Combining the challenges of traditional discrete manufacturing with high regulatory control, Medical Device Manufacturing presents a unique set of business obstacles. Companies today must execute efficiently, keep costs low and ensure compliance, all while consistently producing high-quality products.
To answer these challenges, IndX leverages the Opcenter Execution Medical Device and Diagnostics Suite, formerly known as Camstar, from Siemens Software.
Part of a leading Manufacturing Execution System (MES) offering, Opcenter Execution MDD was designed to enforce the control of the 5 Ms of manufacturing – Man, Machine, Method, Material and Measure.
The system checks that all training and certification requirements are met before allowing any user to work at a particular operation or inspection.
The system ensures that only qualified equipment that is up-to-date on maintenance and calibration is used in production.
The system enforces process sequence, ensuring that all necessary steps and data collection are completed and providing instant feedback to ensure compliance.
Opcenter EX MDD ensures that operators use the right quantity of qualified materials, enforces expiration dates, LIFO (Last In, First Out) and FIFO (First In, First Out) rules.
The system ensures that all required data is collected. Data is compared to specification limits and can automatically trigger rework or non-conformance.
Opcenter Execution MDD is a leading manufacturing execution solution designed for error-proofing processes, paperless manufacturing, electronic device history records (eDHR) and electronic batch records (EBR).
Opcenter EX MDD was built using best practices in medical device manufacturing and diagnostics for faster out-of-the-box implementation. It helps accelerate innovation, reduce costs and achieve the highest-quality products while making compliance a by-product of excellent manufacturing processes.
IndX has a dedicated practice and over 10 years’ experience delivering proven MES solutions like Siemens Opcenter to medical device manufacturers worldwide.
