How to achieve central intelligence

Optimize your IT system architecture with compliance by design

Did you miss the first article in this series: The Data Revolution - Transforming from reactive and risk-based to proactive and value-driven? Read it here.

Data is no good if we can’t get the information that we need out of it. Companies in the Life Science industry deal with mountains of data every day. The question is how to make this data effective and easily accessible. The solution to this challenge lies in your IT system architecture.

The pathway to central intelligence

To increase the efficiency of your data, you must also have efficient and centralized systems.

Transitioning from best of breed to platforms

In our industry, there has always been a focus on choosing the best systems for a given task. In other words, choosing the best of breed. While this detailed, yet siloed method works great for each individual area, it creates no pathway for shared information.  

Holistic intelligence is not supported by standalone best of breed solutions

How can we pave the road for shared information? Start with a platform solution. Platforms not only harmonize different business areas in general, but they also offer the opportunity for shared master data, cross-functional data, and simplified data exchange. This is because having fewer interfaces decreases the complexity, leading to a more robust system that is easier to validate. The first step is understanding the advantages of a platform strategy. The next is determining what exactly your business needs and can get from a new platform.

Business is the driver

Going hand in hand with current best of breed focus is technical focus of our platforms. As mentioned in the previous article, The Data Revolution: Transforming from reactive and risk-based to proactive and value-driven, we need to be more business driven. The technicians may gather the data, but, in the end, it is the business that needs to use it.

That means you must take the time to understand how data is and can be used in the business. You should identify reporting, tracking, and trending opportunities, as well as define both what you need and what you do not need.  

Connection is power

Once you’re working in a platform setup, you will no longer have to create workarounds to connect data. Additionally, connection gives you the power to more easily automate data exchanges and creates a single source of truth for your company’s data.  

Intelligence = data + analytics + receiver

We know that data is only as valuable as the information we get from it. Connecting our data to advanced analytics will help to translate it into useful information.  

Always automate where possible

Information is more valuable than data; however, it has little value if we don’t use it to take action. To reach a stage where data is providing your business with intelligence, there must be a clear path for your information to travel so that it reaches the appropriate people at the right time in the right format.

Compliance by Design: Designing IT Systems for Success

By now, it is safe to say that technology is often a help rather than a hindrance. However, this advantage is often overlooked in Life Science - especially when it comes to data integrity. We get it. You’re used to technology playing a certain role in your business and you’re nervous that relying on it even more will only introduce data integrity risks like CSV, audit trail reviews, true copies, etc.

But you will not move forward with this mindset. Instead, embrace technology and everything it can do for your business when designed properly – including enabling data integrity. This is because IT solutions following compliance by design are made to only work compliantly.  

Paper-based processes often have the same, if not more severe, data integrity risks

How does it work?

Compliance by design works because every step in the process is automated and validated. From the moment the data is generated in the lab, it is automatically sent to the right stakeholders in the right format at the right time. The keys to compliance by design are automation and validation.

Compliance by Design

To put this into context, say the lab generates data. This data would then be sent to your LIMS to be turned into information via storage, processing, evaluation, and review. The information from the LIMS moves to an eQMS where an OOT record trigger occurs as well as investigation and any further actions. You should now have information in the form of analytics and/or a report. At this point, the report reaches the appropriate business owner who could include it in a trending report, use it to assess business impact, and define any further actions.  

Via the business owner, the information now becomes intelligence that can be used for prescriptive quality management i.e., being able to act before an event such as a vendor audit, submission strategy, and more.

Why is this not the standard?

By now, you might be asking if this is so great, why is it not already the standard? Well, because change is hard. As an industry, we have grown accustomed to our current ways of working and have ended up in a cycle of supporting our systems more than our systems are supporting us.

We know our current systems meet the requirements, so the stress of changing our ways of working might not seem worth it. But if we take a step out of our bubble, we can see that the more we trust technology and invest in automation, the more quantitative and reliable our data will become.  

At Epista, we have a dream that the industry will see that data integrity is much more than a necessity. Rather, taking all possible steps to improve data integrity is a move that will support your business endeavors. From increasing quality to keeping costs down, trusting technology improves our ways of working. Get in touch if we can help you transform your data into intelligent information that your business can use effectively and efficiently.

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Oliver Bosch
Director Consulting - Germany

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