Huw Loaring, systems director of LabLogic Systems, considers how far a 'commercial off-the-shelf' or Cots laboratory information management systems (Lims) can live up to its promises
The pharmaceutical industry is under constant pressure from the need to analyse ever-growing volumes of data both cost-effectively and within regulatory restraints, so it is no surprise that it is one of the biggest users of laboratory information management systems (Lims).
Today the acronym on the lips of every Lims salesman is Cots (commercial off-the-shelf) - a reassuring term implying that the product to which it is applied is designed for the purpose that the potential purchaser has in mind; that it can be implemented and validate quickly; and that it will not have to be customised, because configuration will be a natural consequence of application.
The Cots principle of building more functionality into base software so that it does not have to be added when the system is implemented is undeniably a good one (it is taken for granted, after all, in software on which we all rely, such as operating systems and word processing programs), but the crunch comes in the degree to which functionality is constrained by the application to be satisfied - and that will vary considerably from industry to industry.
In the case of pharmaceuticals, Cots Lims providers face a double challenge: their functionality must accommodate itself to the strait-jacket of audit trails and all the other requirements of regulatory compliance; yet it must also be flexible enough for individual users to apply it to their own processes and procedures without undue limitation.
The onus must be on the provider to develop a Cots system that meets the defined needs of the industry, rather than burdening the customer with the expense of customised functionality to bridge 'gaps' that are, after all, not of his making.
Success can be measured in terms of easier and faster implementation and validation, which will incur less cost for the customer and enabling him to realise the benefits of the system with minimum delay.
An ideal solution in a perfect world, then (and straight off the shelf, too, if the Cots acronym is to have credibility), but where is it to be found in practice? The answer has to be that the Lims provider closest to the ideal is one who knows which shelf to take it down from; in other words, one who knows from practical experience not just the industry in broad terms, but the niche (even the niche of a niche) that the customer inhabits.
In turn, that must mean that the provider's expertise has been acquired, corporately or personally, over a considerable time frame - certainly well before the ubiquitous Cots acronym first saw the light of day.
A case in point is LabLogic's Lims, Debra, which is as tightly focussed on drug metabolism studies as it was when it was first created more than 20 years ago - a narrow range that is more than compensated for by the depth of very specialist experience that it incorporates.
Adme - and only Adme - is what Debra is about, and information from its users tells us that they have a similar commitment to the science.
In return, they receive a Debra package that can include validation and implementation services, taking them from installation to 'live' typically in 4-6 months.
Because its realisation is motivated by LabLogic's understanding of the studies users want to carry out (rather than a generic sample-based approach) it is designed from the beginning to realise study objectives.
All of this is carried out by system developers and support personnel with a relevant scientific background, so customers do not have to spend time acquainting their provider with the drug metabolism basics.
Debra qualifies more than many for the Cots acronym because, to extend the metaphor, it has been taken down from exactly the right shelf.
It offers, for example, functionality and modules already configured for a typical Adme application area - study definition - treatment preparation - animal dosing - real-time data collection - labelling - bar-code production - interfaces to LSC, rHPLC, WBA - and full reporting and calculations of all applicable data.
Particular commercial value attaches to real-time data collection, because it saves at least 60% of the time and labour costs incurred by manual spreadsheet-based procedures.
A drug metabolism Lims is not a static system, of course; over time, it must be able to accommodate changes in the demands made on it, whether from individual users, the industry at large, or regulatory bodies.
New shelves will inevitably be required.
Debra is continually developed to keep up-to-date with requirements in specific application areas through LabLogic's annual user group meetings, at which clients can contribute to the ongoing development of the system.
Recent additions arising from this mechanism have included in vitro study capabilities such as protein binding and functionality to enable sample splitting and pooling.
New FDA requirements are acted on as soon as practicable and incorporated in subsequent releases and, looking to the even longer term, future directions for Debra are driven by a group of Adme scientists who are attuned to where the industry is (or might be) heading.
