Lab Data Standards

The primary challenge with implementing instrumentation in the lab environments (beyond the obvious cost issue) is making it work with what you already have in a timely manner, with limited IT involvement. Of course, when working in a regulated environment, this is only amplified by the amount of validation testing required to prove things work as advertised.

In a meeting comprised chiefly of senior scientists, this came up as a discussion point and one of the scientists asked the obvious question –

why can I plug almost anything into my computer at home and it just works, or it downloads whatever it needs and then works, but it takes an IT team and an integration project to get an instrument working in my lab?

Of course, the answer is a little more complicated then just plug and play hardware drivers, but that is one issue. The other is data format and communication. A nice start would be a universal data standard for instrument data that all vendors can agree on and the regulatory agencies support. I have worked in the clinical space on many standards, chiefly around CDISC, but I have not seen the same enthusiasm to date in the labs. Side initiative… figure this out! I am working with a group of folks to identify areas of focus, and corresponding standards that may be emerging. Where there are none, I will try to see what we can get started. I have a couple of notes into the FDA to see what they have in this space and am currently waiting on a reply from a guy in the instrument area...

More to come in this space to be sure...