We LOVE papers in the Pharma industry.
They are crunchy and durable and you can actually hold them. They can be stored in an archive, and you can always go back and check the blue ink signature to verify the original author of the data.
Need to copy this data? No problem! Just transcribe it and have someone else double check the two copies are the same. In comes the blue pen and off we go to another paper-brick in the wall.
You are probably tired by now so I will not continue with the story, but imagine thousands of papers with hundreds of thousands of signatures, being boiled down into a single regulatory submission.
See that number in Table 147, row 15? It seems a bit odd and out of trend. Is it a typo? Or did we not notice an impurity emerging in our product up until now?
Now you tell me, should we postpone the submission to double-check?
As data sets become larger, and markets expect new drugs faster- we can no longer afford the luxury of blue pens.
We must complete the transition to Digital and Pharma 4.0, because the other industries are already at Industry 5.0, and the regulatory authorities are losing patience (and workforce) to paper submissions.
Oh and by the way- your Stability Report.PDF?
Albeit not so crunchy.