top of page

The Documentation Paradox

I have a million photos of my daughters.

Per week.


You can literally run them sequentially and get a stop motion video of every single beautiful moment, and there are so many.

And that’s before mentioning actual videos- gigabytes of videos.


There is an illusion that by capturing those moments, they will somehow not go away.


The reality is that they do.


Try finding a “good family photo” and you’ll see what I mean.

With overly crowded cloud storage, it becomes harder to find what you want.

===


In Pharma we are meticulous in documentation- we are obliged to it by the Good X Practices.


Every action must be possible to trace back to the source data, and every piece of source data must be integral with the end product.


But then someone asks a question.


It could be the regulator in an Information Request, or an investor, or just another team member from across the hall.


And to answer that question we must start looking for the data inside the piles of documents stacked in our company cloud.


It takes time, and time is money, and sometimes we can simply NOT find this data, even though we can swear we recall this or that experiment was done.

===


Just like making an album once in a while can ameliorate the photos-overload crisis, so is capturing project knowledge on a regular basis.


Maintain as few as possible “sources of truth” - make sure to update them with new knowledge, and prune out outdated knowledge.


One such place (for CMC Development and Product Quality knowledge) is Module 3 of the CTD- which is what the regulators want to read when they look into your product’s tangible aspects.


I advise my clients to (AT LEAST) always have an up to date Module 3- it doesn’t have to be polished. It doesn’t have to be submission-ready. Just keep it up to date: throw in the most recent development report version, update that stability timepoint.


Don’t wait until it is needed for submission- reap the benefits of an up to date single source of truth on a daily basis and you’ll see that you are using this knowledge more effectively, more efficiently, and just…. more.


What are your life hacks for knowledge management of your complex development project? 


Would love to hear from you in the comments!


Comentarios


bottom of page