SMART quality & compliance
Keeping Up with Digital Trends
“Enterprise architecture and technology innovation leaders using enterprise architecture to master emerging and strategic trends must plan for a radical, long-term (2020 to 2025) evolution of the user experience for both customers and employees as conversational systems, augmented reality (AR), virtual reality (VR) and continuous/contextual user experiences radically change the way people interact with systems.” Gartner, 14 October 2016 Report. Picture this: presently, a digital stethoscope with the ability record and store data such as heartbeat and respiratory sounds. Tomorrow, the same stethoscope could function as an “intelligent device” by collecting massive amounts of the same data, correlating it with diagnostic…
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SMART quality & compliance
Do It Better And Faster – Batch Management & Global Batch Traceability
“Quality is everyone’s responsibility” – W. Edwards Deming Batch: Material or Product Quantity with similar characteristics Global Batch Traceability (GBT) is a SAP application, which operates across various systems and products. It provides end-to-end batch path, its history, transaction data, purchase orders etc. It builds visible net and links final products with their raw ingredients, services, and resources needed for manufacturing or distribution. It shows batch’s movements from purchase through production and delivery. GBT includes information about all batch changes, leverages, production orders, its dividing processes, direct deliveries and so on. It builds a clear outlook of how batches of…
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SMART quality & compliance
Data Integrity
If you are in the pharmaceutical or in the medical devices industry and cannot sleep at night that may very well be due to a lack of confidence in the integrity of the data of your company or your contract partners such as laboratories and manufacturers. If you are in the industry and are not concerned it might still not be a good sign. As a matter of fact, many companies apparently ignored the risks that lurked within their and their vendors’ systems and processes. Now they have to take the responsibility. Significant reputational damage, import bans, and the immense…
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