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FDA Computer Software Assurance

The U.S. Food and Drug Administration has distributed a draft of updated recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or quality systems. Product quality and patient safety are central to identifying and promoting successful manufacturing practices.  While these recommendations are simply that, recommendations, […]


Benefiting from a well-designed project plan

A significant key to Pragmatyxs’ success is our adherence to a high-quality, repeatable project management process. The commitment to delivering projects on time, on scope, and on budget remains at the core of our work and ensures our customers are long-term clients. Our projects, past and present range in scale and scope from single-site barcode […]


Google Cloud helps manufacturers unify data

  The ability to automate the manufacturing process as much as possible enables companies to leverage time, resources, and effort.  The changing expectations of customers, the uncertainty of the supply chain, and changing buyer behavior make the transition to a more flexible solution even more vital. Google Cloud has launched Manufacturing Data Engine and Manufacturing […]


Four Steps to Reducing Manufacturing Risk

In the industries that we support, compliance, regulation, and requirements, especially as they relate to labeling: is commonplace conversation. What isn’t as apparent is the discussion of risk-based thinking.  “Over the past few years, organizations have begun to embrace an even broader mindset towards risk-based thinking motivated by the growing discipline of regulatory compliance and […]