Our Digitized Mess

As part of our push to become a paperless stability program, we went through the past five years of paper files and scanned everything to PDF. These files were stored on a secure shared drive and can be easily retrieved by anyone granted controlled access. Scanning was a lot of work, but we’ve archived 10 lateral file cabinets of paper and made it so much easier to find information on any study. Information for all new studies is digitized similarly—all the information from manufacturing, release testing, packaging and stability logistics is “PDF’d” and filed in the same shared drive.

My concern is that, after reading the Digitized vs Digitalization article written by Susan Cleary from Novatek in this month’s newsletter (September 2024), I realize that we have digitized, but not digitalized our program. The data generated from our stability studies are housed in a Stability LIMS, but it’s not connected to the scanned information that is critical to the studies. We have to transcribe manufacturing data and release results for example, into our Stability LIMS in order to be able to include it in a report generated by the LIMS. When running statistical analyses of last year’s annual lot with the four previous years we have to collect and compile all of the relevant data into an excel report. While this is way easier and faster than it was, it’s still a delicate and error-prone process that requires verification.

Here's one response: Unfortunately, much of the PDF information is still not going to be linkable to a LIMS, report writer or statistical system without being transcribed. If the last five years of studies are still in a Stability LIMS, I would recommend entering much of the critical parameters from the previous paper files into LIMS fields, and then working with IT to map those fields and the data to a centralized data repository. That’s a lot of additional work, but probably not more than the amount of manual verification you’re already having to do (or at least should be doing).