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Rethinking Processes

Managing regulatory compliance has always been a challenge for organisations, particularly those in the pharmaceutical space. Stakes are even higher today as companies must balance adherence to strict, often exhaustive, and continuously changing policies and procedures with the desire to embrace digital transformation and accelerate business to keep up with growing global competition.

This leaves the regulatory affairs, as well as quality and compliance personnel, in the middle, serving as the conduit between standards bodies or agencies, and senior leadership representing manufacturing, supply chain, and other key operational functions. The back-and-forth can be dizzying as one side expects compliance at all costs and the other desires getting product to customers faster and more efficiently than ever.

Labelling is one such area that crosses departmental boundaries. For manufacturing and supply chain, the barcode label is the passport that enables the fast identification, transport, tracking, and delivery of product from production line to endcustomer. For the regulatory manager, that same label must conform to a myriad of regulations and standards, many of which are a moving target due to constant change.

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Laura Johnson at Loftware brings over 20 years of expertise working with both pharma and medical device manufacturers to improve processes and meet regulatory requirements such as serialisation, UDI, and secure supply chain. Laura’s career has also focussed on the application of technology to drive efficiencies in manufacturing, warehousing, and distribution environments. She is experienced in leveraging core functionality within major ERP systems and implementing automatic data capture technologies such as vision inspection, printing, shop floor devices, barcode, and radio-frequency identification data collection.
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Laura Johnson
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