From a young age, my dream was to work in forensic science. Watching CSI: Crime Scene Investigation, I wanted to be part of the investigation that took place and find answers through science. When I joined university, I expected to spend most of my time in the laboratory using instruments, chemicals and equipment, but I was surprised by how much time I spent in front of the computer, carrying out data review, and checking and completing documentation. I longed to be in a laboratory working on the bench rather than dealing with all the paperwork and procedures that I had to follow, which caused me to question my chosen career path.
However, when I graduated from university, I joined an analytical laboratory which carried out environmental testing and I quickly realized that software was a critical part of the job, and that procedures and data review were always going to be part of an analytical role.
Looking back, this seems obvious, but now, I see how important procedures and documentation are. I used to be concerned when auditors or the quality team came into the lab, reviewing our systems and data, but there is a reason that analytical regulations are continuously evolving, why we have quality departments and standard operating procedures (SOPs) in every laboratory, and why we rely on the data our chromatography data systems (CDS) provide.
It is not just the laboratory that relies on a CDS; we all rely every day on the work laboratories are carrying out; For example, drug testing — or in my previous role — analyzing the water we drink. It is easy to forget the dependence and expectations we have on all forms of product testing and, therefore, our data quality is of utmost importance. Although it can seem an added complication and resource-rich task when working within a laboratory, quality is a topic that we should all embrace, with everyone working together to promote sound scientific practices.
Starting with quality
It is not just auditors and QA/QC managers who must think about quality; the software vendor must also consider this to deliver a quality product. Even from their earliest stages of design, software is developed to ensure high specifications and standards. Software design and development require a solid approach to methodology and testing to deliver a product that meets end-user requirements for performance and confidence in results.
Thermo ScientificTM ChromeleonTM CDS utilizes customer experiences and feedback to design and implement new features. Each feature has a unique user story and is rigorously tested and checked to certify that it is fit for purpose and of high manufactured quality.
Who knew? I certainly didn’t! Back when I was in the laboratory, I was using a proliferation of software and it wasn’t until Chromeleon CDS was introduced that my eyes were opened to how a single platform modern CDS could ease analytical tasks and workloads. It is only when you start working closely with the software that you appreciate the design, and how its functionality is built to give users confidence in their data.
Gaining confidence
This is something I certainly found with Chromeleon CDS. I suddenly found driving data quality became more streamlined, operations were enhanced and with a comprehensive set of tools and controls, the laboratory could more easily demonstrate compliance, accuracy and consistency of data.
For example, eWorkflowTM procedures were put in place. As these were linked to controlled methods and templates, I was reassured that these were protected from change and that SOPs were being followed. Not only that, sequences could be started easier and faster, and I no longer had to worry about accidentally saving over a previously run sequence.
In addition, through system suitability tests, performance checks could be automatically incorporated into our daily sequences. No longer did I have to carry out manual calculations or checks to ensure quality samples were within specifications. Access control was provided through the User Management, system ensuring I could only carry out actions I was trained on. We also started to introduce paperless record-keeping through the use of electronic signatures. Data quality was truly upheld throughout the entire analytical workflow.
It is not just analysts who can benefit from streamlined operations; eWorkflowTM procedures also become less onerous with Chromeleon CDS. Through the extensive audit trails, changes are logged and tracked to record who did what, when and why. Analysts no longer have to try and remember why they have changed integration or re-run a sample. Information captured through the use of privileged actions and comments at the time of analysis will ensure traceability. The entire lifecycle of the data can be understood, visualized and reconstructed.
Assuring quality
Having a modern CDS with these features is all well and good, but a laboratory needs to ensure and demonstrate that its CDS is consistently operating as intended. For this, the software needs to be qualified, validated and periodically reviewed. My colleague wrote a blog post that describes this in more detail here.
Chromeleon CDS simplifies the process of review, is supplied with validation certificates, and comes with built-in Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) capabilities that greatly accelerate these processes, saving you time and money.
Previously, I would find that with increasing regulations, efficiency was sacrificed but Chromeleon CDS showed that it did not need to be this way. System quality comes with vigilance and routine monitoring, and with this in place, you can ensure an audit-ready state.
Conclusion
It was during my time in the lab that I found my true passion: chromatography software. In my mind it is similar to CSI; finding the truth through scientific data, just with more time at the computer rather than on the bench.
Now, as part of the Chromeleon CDS team, I enjoy observing how quality is a key driver for software development and functionality. Supporting the release of Chromeleon 7.3.1.CDS at the start of the year made me reflect on my time as an analyst and how my role would have been enhanced with these new capabilities, and I hope that this also rings true for you.
The topic of quality is complex but ensuring quality within your laboratory doesn’t need to be. At the end of the day, we all want to have confidence in our products, and thus, we should not fear auditors and evolving regulations but embrace them, work with them, and together install trust through our investigations and analysis.
To learn more on how Chromeleon CDS can assist your laboratory quality, please join us for our ‘Built for Quality’ webinar series.
Thermo Fisher Scientific
United States
