Last spring, I was hosting a life science leadership event that we put on in Malvern, PA. We tried to make it a different kind of event, one that was more about education and sharing of ideas. We even had impromptu panel discussions amongst the audience members. But one exchange highlighted a very important topic that was part interpretation, part semantics and part lightbulb moment.The last topic of the day was on the use of SharePoint for 21CFR11 compliant document management. It was being presented by two of our SharePoint experts with one being the technical SharePoint specialist and the other being a life sciences expert. The topic of the moment was digital signature and/or electronic signature. A member of the audience pointed out that it seemed like this term was being used interchangeably when of course, they are not the same from a regulatory point of view. It resulted in a great discussion and one that highlighted yet another difference that a person's filter can create without meaning to. It can contribute to discussions (or sometimes diagreements) between IT and QA people who think they are speaking the same language but in reality the different dialects are getting in the way.
Our technical guy was referring to electronic and digital signature in roughly the same way, simply as a way to differentiate from a hard copy piece of paper. Moving toward electronic records is an important (and soon to be required) trend and there was a lot of interest in the room as to how the new version of SharePoint could accomplish that. But to the QA and life science people in the audience, electronic signature wasn't going to fly with an auditor while authenticated digital signatures were what they wanted to see. Our SharePoint expert immediately demonstrated that you can do both but that five minute exchange taught an important lesson about new meanings to common terminology in the IT world that can raise the hair on the back of a QA person if it means they fear a 2 x 4 from an FDA auditor. I doubt this is the first or only time that an IT person and a QA person saw things through a different filter.
We actually have modified that presentation to include a specific definition and distinction between electronic signature and digital signature as we always get a great mix of IT, QA and compliance people attending. This isn't a tomato/tomahto situation. It's the difference between a ripe tomato and one with a worm in it.
I did learn other great things at this leadership event (which we are repeating next month in Waltham, MA with different speakers).
*Malvern is a city near Philadelphia and Valley Forge and not just a particle size analyzer.
*Sleeping in a colonial era canopy bed is not as cool as I thought it would be when I was five.
*When you agree to film the 75 minute keynote speech, don't forget your tripod.
*When you forget your tripod and have to stand there and film him freehand, don't wear 3.5 inch heels and expect to feel your feet when you have to walk back to the front of the room to introduce the next speaker.
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