The speakers dinner last night was enjoyable and informative. The challenges coming out of the ligand binding labs are the same as those faced by the rest of my clients and center around key information exchange challenges.
As a deliverable set from yesterday, the group discussed several key focus areas, several of which resonated with me.
Data exchange was a hot topic with a desire for standardized information exchange so systems could talk to each other with minimal work. There is already work in the industry on this topic and I pointed to several of the current and emerging transport standards.
Instrument and software validation and the easing of the process was a highly debated topic as it represents so much of an impact for the GLP labs. The options and discussion ranged from validation accelerator packs to FDA recognized validation standards that allow a vendor to certify, reducing the customer level validation to the 20% or less of customization or configuration.
Also discussed was the desire to have a standardized "plug and play" infrastructure for instrument hardware. This spurred a number of discussions around the implications, not the least of which is the need to implement bidirectional communication in the hardware and software layers of the instruments to make this possible. The lack of common standards to build to and a governing body to work with makes this all the more challenging. My suggestion to the group was to not take on this as an outcome, but rather take on a paper with requirements and standards recommendations, that can then be used as a foundation for discussion with the key players. We need to get on the same page with respect to what it means to have integration at the hardware and driver level before we can get to the level of discussing implementation in detail.
All in all, it was good discussion and I am looking forward to my session later today, discussing the ELN and LIMS roles in these and other areas.
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