The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry.

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing processes.

In fact, while the rest of the world continually vies for digital differentiators, only 21 percent of LSOs even view digital disruption as a potential threat, according to PwC’s most recent Digital IQ survey. The causes of LSOs’ digitization reluctance are abundant and legitimate—security, cost, data integrity and validation concerns are just a few—but fears about regulatory compliance are usually at the top of that list.

Despite the main advantages of digitization, it’s understandable for LSOs to worry that rapidly evolving technology will lead to a loss of control and possibly pose a risk to compliance. Many LSOs have attempted to pursue digitization initiatives only to discover their ventures were overly ambitious, poorly defined, or years away from having any meaningful impact. Plus, the velocity at which digital transformation is reshaping consumer expectations, business models, and workforce dynamics seems utterly chaotic in a compliance-based industry.

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Read the full article at:  https://www.qualitydigest.com/inside/fda-compliance-article/eliminating-digital-divide-life-sciences-part-1-compliance-concerns


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