The True Cost of Delaying Digital Transformation in Validation

Change, as they say, is the only constant. For businesses—particularly those in highly regulated industries like life sciences— change can also be expensive, stressful, and easier to ignore rather than embrace. Many industries have undergone a digital transformation in recent years, adopting new technologies and methodologies to streamline, automate, centralize, and generally digitize their activities. But not all companies are quick to evolve. This article will examine the hidden costs of delaying digital transformation, why embracing change is important to success, and steps that companies can take to mitigate the disruption caused by digital transformation.

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Digital Transformation for Life Sciences Companies

The life sciences industry had such a reputation for resisting change that the U.S. Food and Drug Administration?issued a guidance?to help encourage the industry to adopt new technologies. The Computer Software Assurance (CSA) guidance, a streamlined version of Computer System Validation (CSV), helps companies validate new technologies as required by law. Regulatory requirements are a chief reason highly regulated companies can resist change and favour the status quo. Other obstacles include:

1. Cost: Adopting new technology can be expensive, and companies may not have the financial resources to invest in it.
2. Lack of expertise: Implementing new technology may require specialized skills or knowledge that the company does not possess in-house. This can lead to delays while the company hires or trains employees with the necessary expertise.
3. Resistance to change: Employees and management may resist the adoption of new technology because they are comfortable with the status quo or fear that their jobs may be impacted.
4. Legacy systems: Companies may be hesitant to adopt new technology because they have invested heavily in existing legacy systems that are difficult to replace.
5. Uncertainty about benefits: Companies may be unsure about the potential benefits of new technology and may delay adoption until they have more information.
6. Risk aversion: Companies may be risk-averse and prefer to wait until new technology has been tested and proven successful by other companies before adopting it themselves.
7. Lack of leadership support: Without strong leadership support, companies may struggle to make the necessary changes to adopt new technology.

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The guidance alone won’t help companies undergo the stress and expense of onboarding new technologies. But there’s a good reason companies should take the leap and begin their digital transformation.

Opportunity Costs

The opportunity cost of delaying the adaptation of digital technology for life sciences manufacturers is the potential benefits and profits that could have been gained from the use of digital technology during the delay period. In other words, the cost of not using digital technology are the foregone benefits of using it.

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