The Case for Kneat

A digital validation platform isn’t an impulse buy, it must make sense for your organization and the business value needs to be communicated to the executives that control the purse strings. To effectively advocate for a digital validation platform like Kneat Gx, you’ll need to understand the expected return on investment (ROI).

What Is ROI?

ROI is the amount of revenue gained compared to the amount of an investment, in this case the cost of a digital validation platform. Revenue gained has two components, the amount of money made, and the amount of money saved. Properly calculating this requires a solid understanding of the features and functions of Kneat Gx and their value.

Saving Money With Kneat Gx

You wouldn’t be considering digital validation if you didn’t believe there were significant cost savings to be realized, but those savings likely go deeper than you think. We’ll start with the obvious.

Kneat’s digital validation platform completely removes paper from validation processes. Yes, the main reason for this is to streamline validation, make data integrity more secure across the lifecycle, and turn data into a dynamic tool to be leveraged across the organization. But there’s also savings associated with this simple move, including:

• Elimination of office overhead, such as material cost, storage costs, printing and collating costs.
• Time savings with less time spent printing documents, assembling binders, reviewing reams of documentation.
• Fewer labor hours.
• Less need for onsite visits (digital documentation and processes frequently eliminates the need for travel and onsites, which reduces travel costs.)
• More Right First Time and less Corrective Action and Preventative Action (CAPA) which translates to less waste.

Making Money With Kneat Gx

Digital validation isn’t only about saving money, it also has a number of ways to generate more revenue for your organization. Kneat Gx improves quality, productivity, and efficiency. When it comes to revenue, that’s realized through:

• More uptime for equipment for more products reaching the market.
• Faster time to market through streamlined validation.
• More competitive compared to peers (important for SMBs and contract manufacturing organizations (CMOs))

Cross-Organizational Benefits

When calculating both savings and revenue generation, it’s important to look beyond your own role and team. For example, Kneat Gx can be used for the commissioning of a new autoclave. Information needed for that process can be used in later qualification and validation, including equipment validation or cleaning validation activities, saving time for multiple roles.

Understanding the Cost of Digital Validation

Investing in digital validation comes with an upfront cost associated with the purchase of the platform, user licenses, and implementation. These are balanced against the aforementioned savings and gains but must be part of any buyer’s consideration.

To justify the cost, the need must be sufficient. For Kneat Gx, the more widely used the platform, the greater the ROI. Kneat encourages the wide adoption of its platform, however, also recommends a phased approach to implementation.

Scaling With Kneat

Kneat’s customer, MSD, scaled the platform across 27 sites using just such an approach. MSD selected Kneat with the goal to expand across their global operations. After their implementation, they realized greater than 50% cycle time reductions for execution and consolidated process steps from 15 to eight.

MSD’s phased approach had three stages:

• An initial pilot launch at a single site.
• Seven ‘early adopter’ sites.
• Global rollout to 19 additional sites.

A phased approach such as this can be more palatable to senior leaders as it allows for some cost deferral, increases flexibility within the organization, and reduces the disruption that is part of any learning curve.

Read more about MSD’s experience with Kneat’s global rollout.

Building a Business Case

After the work to understand and measure the revenue generated and the costs accrued, the standard formula to calculate ROI is (amount gained – amount spent / amount spent) x 100. So, if your revenue is 15 and your cost is 5, 15 – 5 is 10, 10 divided by 5 is 2, multiple by 100 you’d express ROI as 200%.

Kneat can help you determine your ROI with our purpose-built ROI calculator. Kneat’s digital validation experts have created a short questionnaire that helps determine the value of Kneat Gx for your organization. Request your ROI calculation here. 

ROI is a core part of any business case, but more goes into a pitch than the cold numbers. When presenting a business case to your leadership team, we recommend:

1. Breaking down validation projects into tasks and milestones.
2. Estimating each item in the list for those tasks.
3. Calculating the number of team members involved and their hourly rates.
4. Adding those estimates together.
5. Add dependencies (such as reviewers required).
6. Comparing the cost of the software.

It’s also important to tie the business case to organizational goals, such as a shift towards digital transformation, or a focus on quality.

How Kneat Gx Delivers for Your Organization

Kneat is purpose-built for life sciences organizations, featuring fully 21 CFR Part 11/Annex 11 compliant digital validation. Turn your data and documents into tools that enhance product quality and accelerate production, delivering significant ROI and positioning your organization for success now and into the future.

Our Kneat Gx Solution Overview walks you through our platform and shows why Kneat is the chosen platform for eight of the Top 10 global pharma companies.

Get Your Kneat Gx Solution Overview

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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.