Chromatography Data Systems in Action
Chromatography Data Systems (CDS) have developed rapidly over the last 30 years. These increasingly sophisticated systems manage instruments and chromatography data, often sitting alongside Laboratory Information Management Systems (LIMS) in an organization’s informatics toolkit. In this blog, we sit down with Quotient Sciences’ Senior Director, Analytics, Justin Holland to discuss how his company use CDS to make their analysis easier to handle.
Ruairi Mackenzie (RM): What can you tell us about Quotient Sciences?
Justin Holland (JH): Quotient is a pharmaceutical services company that is dedicated to accelerating the development of new drugs for patients around the world. Quotient provides CRO (contract research organization) and CDMO (contract development and manufacturing organization) services, including formulation development, clinical pharmacology trials, and clinical and commercial manufacturing services to the pharmaceutical and the biotech industry.
RM: Why is data integrity important within the CRO and CDMO space?
JH: We are a cGMP compliant business involved in the manufacturing and clinical assessment of new drug products. As such we place strict controls on data integrity and have processes in place to ensure that data we produce is accurate and fully traceable with an audit trail. Any electronic systems that we use to record, analyze and report data must be validated to make certain we are reporting true results to protect the safety and wellbeing of clinical trial volunteers or patients.
RM: What were the challenges you faced before adopting a CDS?
JH: Before we adopted the CDS, we used a predominantly paper-based system which was not only bureaucratic but made audit trails very complicated.
RM: When you are working with different companies – Quotient has up to 300 clients – are there security challenges in keeping that data distinct and discrete?
JH: In client audits, (we have on average 1 per week) the chromatography data system that we use is always an area of focus, and they do want to understand how the data generated is recorded, analyzed, checked and stored. But I think as soon as you say that you're using a system that everybody recognizes, it allays their concerns.
RM: Are there any particular features of the CDS that Quotient uses that you would highlight?
JH: From a compliance perspective, one of the key things that auditors and regulatory agencies tend to be interested in are who can do what, with particular attention on ensuring that analysts can't delete data or audit trails. I think that's probably the level of detail that the auditors always want to know. Having a CDS makes answering these questions easy.
Furthermore for the analysts, features like being able to overlay chromatograms simply is a god-send, and very straightforward to use. Chromatograms can easily be aligned due to slight differences in retention time, then you can use the system to do that and try and figure out what are placebo peaks and what aren't placebo peaks. It makes data analysis so easy.
RM: In your field is it now standard for companies to have a CDS in place? How successful has CDS adoption been over the years?
JH: Yes. I can't speak for everyone. As I mentioned in my presentation, I know that four years ago, there was a lot of companies being audited and getting observations for not having a EU GMP compliant CDS in place. It is a regulatory expectation, if you don’t have one it’ll be very difficult to justify the integrity of your data. That said, implementing one is a big project that needs to run in parallel with whatever system you’re currently using, and the regulators appreciate that, but the benefits in terms of quality assurance and efficiency are well worth the effort.
RM: What would you say to a lab that is maybe a bit behind where you are, and is looking at adopting a system? What would you say is the biggest advantage?
JH: Without a doubt, implementing a robust CDS ensures compliance with regulatory expectations, but more than that, you can improve your workflow, increasing efficiency and reducing wasted time. For example, some CDS allow the analyst to input how many samples they are testing and will automatically populate everything else. You put your vials in the right place, it'll do the full analysis for you, and it will do the calculations on the back end, and give you a report, with an auditable trail. So, as well as being in compliance, it will speed up the whole process and reduce the amount of time that people spend checking data.
Justin Holland was speaking to Ruairi J Mackenzie, Science Writer for Technology Networks