original

What Art and Science Have in Common: Only the Original Counts by Stephen Ferrell | August 17, 2018

When modern GMPs were first developed in the 1970’s, few peripheral industries benefited more than the manufacturers of blue pens.

Our younger readers may already be lost at this point, so for their benefit I’ll explain: most early photocopiers could only reproduce in black and white. This meant that having both a photocopy and an original document printed with black ink could be very difficult to tell apart, but using blue ink would always make it clear to the auditor which one was the original. This simple method was so reliable that some organizations began to require it. Life Hacks were a lot harder back then…

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Because You Needed it Done Yesterday: Keeping Data Contemporaneous by Stephen Ferrell | August 3, 2018

Time in the lab is a resource as precious as any instrument, test, or person. Many a fine lab technician has felt the need to find more; to time travel in a sense by recasting or fitting results into a more convenient window. I’m speaking of course about backdating.

Backdating is the original sin in a GxP environment. We are all told in our orientation not to, but it is almost assuredly the first temptation that we face. Backdating has many seemingly reasonable justifications, ‘no one will know’, ‘what’s the harm in it?’, etc. etc. Here is thing to confront: there is always harm in it. If you have backdated, one of the following things has occurred…

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Why the Pen is Not Always Mightier: Legibility in Laboratory Data by Stephen Ferrell | July 20, 2018

Have you ever been told you ‘write like a doctor’? If you have, odds are it wasn’t a compliment recognizing your superior cursive or your masterful ability to spell ‘acetaminophen’ without a spell check. It’s much more likely to have been a lament over the indecipherable scribble you’ve just jotted down. Fortunately, the art of writing with a pen, pencil, or ink-dipped quill is fast disappearing as an elective form of official data capture or communication.

Although laboratories are the very image of modernity in so many ways, they have been uncharacteristically slow in accepting the obsolescence of trusty old writing implements…

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An Admin by Any Other Name: Making Lab Data Attributable
by Stephen Ferrell | July 10, 2018

“My name is Connor, here’s my letters: C-O-N-N-O-R!”

To my four-year-old, attribution is fundamental to his daily interactions. He is often surprised and bemused when he meets other Connors and even more so when they spell their name with only one ‘n’. The importance of being unique and identifiable is something we all learn early in life, and while it may get a little less exciting as we get older, it doesn’t get any less important…

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Addressing Data Integrity in the Age of Sticky Notes
by Stephen Ferrell | June 11, 2018

In 1992, I entered my first lab: a land of Bunsen burners, pipettes, test tubes and a kaleidoscopic selection of oddly colored sample jars. Within 20 minutes, my lab partner and I had spilled 4 molar Hydrofluoric acid into an electrical outlet and my scientific career went up in literal flames. For reasons you might guess, it was not until almost 10 years later that I found myself in the lab again. This time I was validating 21 CFR Part 11 compliance solutions that had been installed across all the PC’s in the lab – less fun and dangerous.

In a lab replete with Mass Spectrometers and HPLC systems, there was one tool that stood above the rest…

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