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Why the choice of your MES matters when it comes to meeting changing regulatory requirements and setting up a world-class QMS.
In a digitized CAPA management system, actions and alarms are triggered automatically, and containment action may begin almost immediately once an event is detected.
It is due to the self-actuating nature of DataOps in capturing, streamlining and enriching data that it is gaining popularity in the Regulated industry segments.
This distinction between industry segment needs is a primary reason that MES products are specialized by industry. Getting a MES/QMS system that captures the distinct processes, nomenclature, manufacturing modes and quality regulations is driven by industry-specific functionality. The selection of a specific vendor should include the focus, functionality and roadmap for that industry.
The Semiconductor Industry has been at the forefront of digitalization. Chips manufactured by the industry have enabled increased data storage, real- time data processing at the edge and the very manifestation of IIoT and AI in value chains worldwide. However, the automotive and medical device industries are outpacing semiconductor in terms of digitalization, with the semiconductor industry lagging behind.
The Automated Validation approach is crucial in helping companies to reduce the time and cost of their validation efforts by at least 60-70%.
As the medical device industry grows despite the pandemic (current research shows a 7% market growth) the need for an MES for process oversight and guidance becomes an even stronger argument.
The challenge with a QMS is that it is often a standalone system with a reactive approach to quality issues, whereas the manufacturing process requires a proactive approach to quality. Our argument is that a Manufacturing Execution System MES or MOM solution is a necessity for your holistic approach to quality, and we offer you ten reasons why MES should be the backbone of your quality operations.
The urgency of response to Covid-19 and the market whiplash are causing MedTech companies to rethink their product mixes to either innovate or partner with other technology companies to answer the pandemic needs. MES has reinforced its place as a critical component in GMP for these companies.