If your laboratory is operating in a regulated environment, then you are faced with the challenge of ensuring your operations and systems are ready to withstand the scrutiny of a regulatory audit, or else face the consequences. But depending on your industry and your environment, different regulations may apply. For laboratories using computerized systems to support manufacturing operations in the pharmaceutical industry, you will be concerned with GMP, GLP, 21CFR11, and Computer Systems Validation (CSV). In this environment your laboratory informatics systems (LIMS, CDS, ELN, SDMS, instrument systems, etc.) are expected to be validated for intended use.
However, all of this should be of no surprise to you as laboratories supporting pharmaceutical manufacturing have been dealing with CSV requirements for quite some time. In fact, your organization most likely has well documented interpretations of the predicate rules and has established a standard CSV process. You know how to validate computer systems, and maybe you have even started to think that “Validating a laboratory informatics system is like validating any other software system – It’s like a commodity!” But is it really?
If you follow the same processes and procedures, create the same set of documentation, and provide the same basic evidence for all your computer system validations, you have certainly standardized CSV, at least from a macro point of view. In other words, there will be no appreciable differences between validation of System A and validation of System Z. In general this is actually a good practice as it improves the quality and consistency of your validation projects. However, as you get into the specifics of what will be tested, and how and to what extent, based on a well-documented Risk Analysis, your validation projects should no longer have the same fungibility (huh? When did we start talking about mushrooms?). Fungibility is the property of a good or a commodity whose individual units are capable of mutual substitution. So when you start getting into the details of a validation project, each one will be different and this is as it should be.
Another aspect of the commoditization of CSV that you might be thinking about is the profiles of the resources that you use to plan, design, and execute the validation. Much like the CSV standardization we described above, it is understandable that at a macro level one could postulate that your CSV resources are fungible. After all they will be using the same standardized CSV process, won’t they? But when you start getting into the specifics of each particular CSV project, the commodity nature of your CSV resources will disappear.
“The Devil is in the detail” is a very appropriate saying when it comes to lab informatics CSV. From both a process and resource point of view, these validation projects can’t be treated as commodities except at the highest macro levels. The complexity of laboratory informatics systems (e.g., LIMS, ELN, etc.) and the myriad ways that labs utilize, configure and customize them requires detailed planning, documentation and thorough risk based assessments to be performed. In addition, how to test one line requirements such as “The system shall support dissolution testing in accordance with USP 711” requires scientific knowledge. In order to do all this efficiently, generic validation and/or IT personnel (i.e. commodity resources) are suboptimal resources in this space. In these situations you need to supplement your validation team with lab informatics validation Subject Matter Experts (SMEs).
It is very important when considering the use of SMEs that they not only have expertise in the specific product(s) you are validating, but also in the regulated laboratory environment you are operating. Remember, while most lab informatics systems provide similar functionality, how that functionality is provided to the user and what the underlying architecture and data structures are can vary greatly. So utilizing a lab informatics validation SME with specific expertise of these products is critical to your success.
Do you feel that validating a lab informatics system can be treated as a commodity? Have you successfully validated a lab informatics system using generic validation and IT people without tying up lab resources? Have you supplemented your validation team with lab informatics validation SMEs? If so, did they provide you value?