Are too many square pegs and round holes getting in the way?
With the increasing globalization of bioanalytical (BA) operations, there can’t be many labs anywhere in the world that aren’t looking for ways to improve their productivity and reduce their cost basis. But with few, if any, meaningful gains possible on the operational side, one needs to look elsewhere in the process for these advances.
I’d like to propose that better data management and streamlined reporting are potential candidates for the next quantum leap. Improved ways of capturing and organizing both structured and unstructured data; enhanced workflow and process management; automatically enforced QA and superior reporting capabilities – that’s the holy grail we are all seeking. You only have to look at forums debating bioanalytical issues, such as on LinkedIn, to realize the capabilities that people crave.
A LIMS can, and does, play its part in the BA lab. But for added flexibility, new generation ELNs have much more to offer – provided they operate as needed in this highly specialized environment.
Many are the times that I have seen an enterprise attempting to utilize the instrument-bundled capabilities of an ELN, but it appears they are trying to fit a square peg ELN into a lab system with a round hole. Hammer it home hard enough and you will make it fit … but it cannot deliver all the benefits required to be truly beneficial. What you need is a platform neutral ELN solution that gives total access to your data and integrates intelligently with your existing processes.
Call me biased if you like, but there is already an ELN that delivers all that and more – the highly scalable E-WorkBook suite from IDBS. It improves to let you create your own unique methods, enforce compliance with them, and flag any deviations. But it’s not just me saying it. Ronald Shoup, from AIT Bioscience recently commented, “We adopted E-WorkBook to provide bioanalytical preclinical and clinical study data at a faster pace, with higher quality and at higher efficiency.”
Perhaps the most critical aspect of a bioanalytical study is its reporting. Every lab that submits bioanalytical data to a regulatory agency, in this case the FDA, has to comply with identical guidelines. Yet all labs works differently, which can make the reporting process hugely resource intensive. LIMS can help reduce the burden in key aspects of lab operations and is widely used. However, it has deficits in areas normally associated with an ELN – lab functionality as well as process improvement capabilities without the rigidity you expect from a LIMS. To put it simply, choosing the right ELN solution can help you collate your data across multiple runs into a single report, in an easy to use utility (say, Microsoft® Word), resulting in time saving. Some labs that have deployed E-WorkBook Suite have estimated savings of up to four weeks. If you’re a CRO imagine the difference that could make to your productivity and your bottom line.
If ELNs are the shape of things to come to improve productivity in bioanalysis – and I believe they are – it makes sense to choose a solution that won’t fall apart regardless of the operation you’re trying to improve.