The Evolution of Laboratory Informatics
Kate Thysse, Scientific IT Specialist at Lonza, speaks to Pharma IQ about the evolution of laboratory informatics. Thysse also reveals her top 3 tips for overcoming challenges relating to regulatory compliance within the world of lab informatics.
Pharma IQ: In your opinion, how has laboratory informatics changed and evolved in the last few years?
I see laboratory informatics have changed the way they are offering software packages and rather than having just one software that will solve everything, they’ve moved to having more of a modular approach to it, so that customers can pick and choose what sections sort of fit in with their own requirements.
And why do you think it's changed like this?
The pharmaceutical industry and the lab informatics affect and drive one another. The industry has a very complicated mix of processes and requirements with another added hurdle of having existing systems where one software package simply does not solve everything that they require. We have seen that the lab informatics products end up having to change to fit into what the industry requires.
What impact do you feel the change in nature of laboratory informatics is having on the rest of the pharmaceutical industry?
I think from their point of view, you are just unable to have one software that will solve everything. So you have your ELN/LIMS/LES which will capture all the experimental data, and then you have the contributing softwares e.g. sample management, operator scheduling, data trending etc. There isn't one software that can do that and also fit into the existing software architecture.
The industry seems to have accepted that, and so what they would rather do is have individual software which perform very specific activities and that the data might not flow seamlessly but place other measures in place to guide the data flow.
What are the top challenges relating to regulation in compliance within the world of lab informatics?
The data may be created in silos but it definitely moves between them. Understanding where the boundaries are between the software systems is key. For example if you have a Chromatography Data System (CDS) and Electronic Laboratory Notebook (ELN), both have the ability to record and trend the data but one must be the leading system for a task (only use the ELN to trend data) or a data type (chromatography data is only recorded in the CDS).
One needs to understand the data flow process between the systems. Normally companies have great control on individual systems, but they might not maintain the same control for the contributing software which interact with that system.
What are your top tips for tackling these challenges?
1) State which software is the leading software (which system performs which task).
2) Think globally and ensure the company moves together for a new software implementation.
3) Perform a risk assessment on the whole data flow and not just the system.
Your talk will focus on the regulatory side of informatics in a laboratory, particularly with the processes you have introduced to tackle regulation; what were the most important things that you considered when putting into place a strategy like this?
This is not an easy task to tackle, therefore focus on the root cause rather than the direct cause. Identify what the problem actually is; is it that the data is at risk, are the people at risk, or is it the process that is at risk? To create a risk assessment delve deeper into the issue. Take into consideration why the new strategy is required, who needs to be taken into account? For example, is it just the user or are you going all the way up to the auditor and understanding what they require? You also need to think about what data is available to discover the root cause; which sections of the business are affected, and what are your inferences of the strategy?