Original Article posted on LabManager, December 08, 2015
Volume 10, Issue 11 | Ask The Expert
Michael Barkan is a senior informatics consultant at CSols Inc., a North American laboratory informatics consultancy with offices in Canada and the US. Previously, he worked for Johnson & Johnson in global laboratory systems for 21 years, where he was the administrator for the chromatography data system (CDS) for laboratory benchtop systems, running validations for the organization’s FTIR, UV-Vis, mass spectrometry, atomic absorption (AA), and other pieces of lab instrumentation.
A: With both consulting and having the opportunity to do work in the laboratory managing chromatography data systems, I would say the most recent trend right now is that there’s a big push for metrics. That relates to things such as how many injections a particular system or analyst has done—systems utilization through those metrics—and which systems in the lab are high-use or low-use. That then allows managers to do some investigations into why that’s so, probably by asking the analyst, for example, why they don’t use this particular piece of equipment often. There’s also a focus on wanting to know the throughput of samples in the laboratory. Lab managers are starting to dig in and ask those questions, and the chromatography data systems are actually starting to have these metrics modules as part of their packages.
A: Of course, the standard chromatography features are built in, but the added features that they’re looking for are linkages to other systems to make things a little bit more efficient, so that the chromatography data system can connect into LIMS or other pertinent systems where data can be transferred.
A: Everybody’s looking to create efficiencies, so they want the CDS to fall in line with helping to create those efficiencies. There’s also a big push within the FDA right now for data integrity, so lab managers are looking for the CDS to be a compliance tool, where it’s locked down so that there are no questions about compliance.
A: Often the first thing I notice when I go into a company is that there are three groups that you have to deal with: the IT department, the business or laboratory that wants the system, and the compliance or the quality department. One frequent challenge is getting all three of those functions in agreement on different things that come up during the planning stage. Another difficulty in implementing a CDS is that most labs have a mixed bag of equipment and you really have to go digging in the laboratory and do your homework before you start to generate a list of the equipment that’s in place—and also the equipment’s firmware—so you know whether or not this equipment is compatible with the CDS that you purchased.
The other difficulty that I’ve encountered in the implementation process, especially in a global or multisite install, is the issue of harmonizing processes between the different sites. If you’re using a system one way and you have sites out there that are doing things differently, it becomes very difficult to implement the system. You have to do a harmonization of processes among the sites before implementation starts. Then during the implementation, getting consensus on direction—should you get to a point where a decision needs to be made—can be a challenge.
A: The project manager really has to be a strong leader on the project and has to come to the table with those groups [IT, business/laboratory, compliance/ quality] from the outset. The project manager should meet with them before the implementation actually starts to lay out some ground rules, and ask some questions with deadlines that need to be answered by that group. They need to then come to the table in agreement so that they can write their validation plan and deploy it in a way that would fit the bill for all of those groups. They also have to be proactive—collect the equipment, the firmware, all of that—from the outset and determine right away what’s compatible and what may need to be upgraded before implementation is started. It’s really hard to do that in the middle of a project. In most cases, they’ll want to generate a new set of procedures around the CDS that everybody can follow.
A: When you’re deploying a new chromatographic system, a lot of people want to choose one that’s easy to use. But what I found in my experience is that the ones that may be easy to use may be less compliant. So if you pick one that’s more compliant to alleviate that concern, you have to recognize the fact that more training is going to be required.
The training should be for all the analysts, especially if they’ve never seen that type of system before. What I’ve done in the past is hold a weekly Q&A session so that over time, as users start to get their questions answered, they ask better questions. The training is ongoing until it’s no longer needed.
When deploying a chromatography data system, it’s always good to have an environment in which you not only do your daily work but can also “play.” One where people don’t have to worry about breaking things and they can try new things, or new equipment can be installed to see if it works, because then you don’t have to put your production environment in question. People deploy chromatography data systems either with full clients or in a Citrix environment; if it’s a validated chromatography data system, going by way of Citrix is a much better option because there’s less validation for that choice since it sits on a server.