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.

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.

For life sciences manufacturers, digital technology can bring significant benefits such as improving efficiency, reducing costs, accelerating product development, enhancing quality control, and increasing customer satisfaction. Delaying the adaptation of digital technology can result in missed opportunities to gain these benefits and falling behind competitors who have already adopted it.

Moreover, in the fast-paced world of technology, the longer a company waits to adopt digital technology, the more difficult it can be to catch up with competitors and adapt to changing market trends. Companies that delay digital adoption may find themselves at a disadvantage compared to their peers, which can result in lost market share, decreased revenue, and decreased profitability.

Therefore, the opportunity cost of delaying digital transformation for life sciences manufacturers can be significant, both in terms of missed opportunities for benefits and increased risk of falling behind competitors.

Digital Transformation in Validation

Validation is a critical component of manufacturing, from the commissioning and qualification of facilities and equipment to the computers that make sites run. Almost every aspect of manufacturing requires validation in some degree and many companies rely on inefficient paper-based practices to execute their requirements.

Digital validation is the execution of validation processes done leveraging technology. We explore the digital validation landscape in detail in The Digital Validation Handbook.

There are many benefits of digital validation, such as:

• Automatically generated audit trails
• Centralizing information for faster access and increased transparency
• Faster text execution
• Guaranteed 21 CFR Part 11 compliant data management
• Reducing the risk of human error
• Removing redundant steps such as repetitive data entry
• Removing the need for paper storage and manual access

These benefits typically outweigh the upfront and recurring costs associated with deploying a digital validation platform such as Kneat Gx. For example, Kneat routinely shortens validation life cycles by 50% or more, resulting in hundreds of thousands of dollars in savings for its customers.

Is Digital Validation Right for You?

When digital validation is done right, it results in savings greater than the cost of implementation, removes risks inherent to traditional legacy approaches to validation, and increases productivity to deliver a significant competitive advantage. So why isn’t everyone doing it? The short answer is trust.

The pharmaceutical industry is heavily regulated, and any new processes must comply with various regulations and standards set by government agencies. Compliance can be a time-consuming and expensive process.

Any new process must be assessed for potential risks to patient safety and data integrity. Risk management must be integrated into the development and implementation process to minimize these risks. For many years, there simply was no solution on the market that could meet the uniquely high demands of the industry.

Kneat was founded by former-life sciences professionals, intimately familiar with the challenges of validation in the industry. The platform was painstakingly developed and tested with the deep involvement of industry professionals, purpose-built for the rigors of pharma and similar industries. We maintain a team of process engineers who are experts in life sciences validation so our product stays up-to-date with emerging trends.

See how Kneat can streamline your validation, remove your risks, and increase your productivity. Request a personal demo today!

About the Author

Tristan Worden – Senior Content Marketing Strategist, Kneat

Tristan has over a decade of experience communicating complex ideas to both general and specific audiences with almost five years in the compliance and validation sector. He is passionate about ensuring validation professionals have the information they need to do their jobs effectively.