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Validation using Agile in the Life Sciences and Health Care Industry

The Life Science and Health Care Industry (LSHC) has always been in the lime light for its strict regulations. Though these regulations are cumbersome, they are deemed necessary in order to comply with patient safety and product quality. In line with the strict regulations, the traditional Waterfall Method was always used in Software Development in LSHC industry.

In recent years, the aspect of being cost –effective whilst not deviating from the regulatory framework has been repeatedly discussed.

The advent of Agile Methodology has disrupted the traditional development methods with its clear focus on continuous development, agility and over all “lean” concept.

“Agile” was introduced as a means to tackle the limitations in Waterfall and other traditional development methodologies by concentrating on continuous improvement and conducting tests in smaller iterations, all the while not compromising on the development quality of a product.

The question then raised by experts was:

Can agile work in regulated environments where the primary focus is not speed but compliance with a strong focus on product quality and patient safety?

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