Hey, does this sound familiar: The lab just bought a new [Enter Name/Type of Instrument or Data System] before the fiscal year closed. It just showed up and now they are after you to validate it now!
Get it done fast – right, no problem but validating a scientific instrument software or lab data system, whether a LIMS, ELN, CDS, or other instrument system, requires a lot of effort, time, and resources. Sure, the software or instrument vendor can provide IQ and OQ kits and services to help ease the burden but that’s not a complete validation solution.
And even if you have the best computer system validation processes, a complete set of deliverables (URS, FRS, Configuration Spec) to work with, and an experienced validation team, getting these projects done fast is rarely possible. Chokepoints, like “the Borg”, are inevitable! Some of these include:
So how do you overcome these obstacles? You need people who know the scientific software systems and how they are used in the lab. That’s right (gasp), you need access to lab staff; the super-user of the LIMS, the scientist that runs the mass spectrometer, etc. Unfortunately, these individuals are rarely available. They have that pesky “real job”, the lab work and science stuff. So scientific software validation projects take forever and the systems remain non-operational, and unavailable. And guess who gets the blame?
Without resorting to kidnapping the laboratory staff and performing a Vulcan mind-meld on them, the way to get your scientific software validation project going is to gain access to other sources of scientific software Subject Matter Experts (SMEs). Now, it is very important to define exactly what one means by scientific software SMEs because in the world of scientific software, “a rose is a rose is a rose” is definitely not true!
Let’s take LIMS as an example. Anyone in the LIMS industry, especially the LIMS vendors, would agree that all LIMS are not the same. Now we’re not talking about LIMS capabilities where the distinctions between systems can be blurry, we’re talking about exactly how each LIMS system implements those capabilities and how they are structured, architected, and operated. Therefore, a SME of LabWare LIMS is not necessarily a SME of Thermo SampleManager LIMS.
Another aspect of the scientific software SME is their specific industry and laboratory expertise. This is important because if you are going to utilize the SME to help with your risk assessment, test script development, and test script execution it is imperative that they understand the environment in which the particular scientific software is to be used and validated within. As an example, the operation, work processes, analyses, etc. and therefore the critical needs of a pharmaceutical quality control lab are very different from those of a pharmaceutical ADME/TOX laboratory. Yet, a LIMS system operating in each of these environments needs to be validated.
The solution to speeding up your scientific software validation project is to engage a SME. Further, a high value scientific software SME needs to have specific expertise with the scientific software system and the environment (industry, lab type) in which the system to be validated will operate. Lastly, while not critical but certainly helpful, is if your scientific software SME is also an IT and regulatory expert as this will further speed up your project.
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Tell us about how you overcame the expertise bottlenecks in your scientific software validation project. Did you gain access to the laboratory staff? Did you engage a consultant to be your scientific software Subject Matter Expert? If so, did they have the specific expertise your needed?