Moving beyond the last frontier of paper

Dec. 5, 2019
Hear the current regulatory perspective on digitalization and what that means for pharma from a former FDA auditor
“I can tell you from someone who has been in the field as an auditor that it’s easy to go into any office and pick apart any paper-based product mostly due to human error — missing fields, unreadable documents or not having the correct version labeled,” says Bryant Headley.

"The big issue is truly the human factor — missteps as well as illegible chicken scratch from well-intended employees.”

The quality challenges that come with paper-based systems are numerous:

  • Data is scrawled on scratch paper and transcribed later – often incorrectly
  • Potential for inaccurate or missing values
  • Values might fall outside of an acceptable range
  • Issues with procedures or materials might go undiscovered until after a batch of product is completed and ready to ship

Ultimately, having a computer-based system lets you focus on what’s actually necessary – the quality of the product you are producing. Hear why Bryant believes survival depends on digital. “You really don’t want to be left behind.”