Life Sciences Software: Risks and Reward of New Technology

The life sciences industry isn’t your typical manufacturing sector. The products are among the most highly regulated on the market, the processes are exacting with no margin for error, and the landscape is highly competitive. With that in mind, it seems life sciences companies would jump at the chance to implement software to streamline processes, but adoption remains slower than other sectors. The reason may be the validation requirements regulatory bodies impose on manufacturers.

In this blog, we’ll look at life sciences software, the potential benefits of new software, challenges in onboarding it, and how to overcome these obstacles so you can reap the rewards and mitigate the risks.

Understanding the Landscape of Life Sciences Software

Before delving into the nuances of validation, it’s crucial to grasp the vast landscape of life sciences software. From laboratory information management systems (LIMS) to electronic data capture (EDC) platforms, and from regulatory compliance solutions to clinical trial management systems (CTMS), the array of software options is expansive.

These software solutions are designed to address specific needs within the life sciences ecosystem, offering functionalities tailored to the unique requirements of research, development, manufacturing, and regulatory compliance. Whether it’s optimizing data management, streamlining workflows, or facilitating collaboration, the right software can be a game-changer for life sciences companies.

Benefits of Life Sciences Software

The exact benefits of any life sciences software are dependent on the software itself and the reason for its purchase. That said, we can still examine potential benefits at a high level, such as:

Streamlining Processes: Software can eliminate manual steps, making execution faster and more reliable. It also makes it easier to access or share documentation, a crucial factor in any life sciences manufacturing process.

Enhancing Compliance: Life sciences software should be designed to meet the rigorous regulatory requirements impacting organizations in this space. As such, it should have rules in place to enhance compliance, such as built in data integrity features to align with 21 CFR Part 11/ Annex 11 rules.

Deeper Insights: Software is a crucial piece of the Industry 4.0/Pharma 4.0 puzzle . It’s able to help users analyze the massive amount of data that is available to life sciences professionals. This includes rapid risk detection, validation documentation tracing and tracking, deeper business dashboards, and overall Enterprise Resource Planning (ERP) solutions, just to name a few.

Further Enablement: Digital maturity is considered an “enabler” of Industry/Pharma 4.0. This means that to unlock the productivity and risk mitigation benefits of this digital transformation, companies must reach certain stages of digital maturity — that means new life sciences software.

Challenges in Implementing Life Sciences Software

There are always headaches in buying software, anyone who has bought a new smartphone knows that, but the challenges for implementing life sciences software are a step beyond that.

Validation

The first concern — and one the U.S. Food and Drug Administration (FDA) considers the main driver of slow adoption in the life sciences sector — is computer system validation  (CSV). In 2022, the FDA released a draft guidance on expediting CSV using Computer Software Assurance (CSA) , a risk-based approach to validation. The FDA is actively encouraging companies to adopt life sciences software and other technological innovations that will drive enhanced patient safety.

Traditional CSV treated all software related to GxP the same, requiring extensive testing and documentation. This meant expensive and time-consuming implementation procedures, which were seen as prohibitive to many in the life sciences sector. With CSA, software is tested when deemed to be a high-risk to patient safety, and less risky applications can rely on either vendor testing or less scrutinous testing to expedite validation and thus implementation.

For life sciences companies, validation software itself can be a great first step to achieving digital maturity. In our eBook, Pharma 4.0 & Digital Validation , we outline why digital validation software accelerates Pharma 4.0 adoption and can help life sciences companies get to market faster.

Resource Allocation

In a budget conscious environment, the initial cost of software may be a barrier to procurement. Software can be expensive, and most Software-as-a-Service models carry annual fees. It’s important that a company do its due diligence to understand where the savings will come from to justify the expense.

Training

New software will require changes to established processes and that means training personnel in its use. Training is time-consuming and takes resources away from their intended function. However, the right software makes up for this initial investment by enhancing productivity and ultimately accelerating life sciences production.

Some mitigating measures can be taken to avoid this barrier. For example, some software, such Kneat Gx , is designed to be user-friendly, based on the documents and processes professionals have been using for years. Additionally, Kneat offers Kneat Academy , a dedicated training program to help onboard and upskill validation professionals.

Conclusion

Life sciences software is usually a significant upgrade to companies that are positioned to take advantage. While any software carries with it some challenges, they should outweigh these risks with their benefits.

If you’re interested in learning more about Kneat Gx, register for our upcoming demo webinar.  You’ll see it in action and have the opportunity to ask an expert about the areas that interest you most. Don’t miss out!

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.