I find myself in a job I never expected to be in.
We are using google docs to do document control and google sheets to track things … We are small so buying expensive packages to do this stuff is not something we will be doing soon… but we need to get certified to be cGMP “like” and will be audited by a 3rd party for compliance…
In this type of situation even for commercial software one has to validate their particular use of the software…
I know I have to write SOPs defining how we use teh software and how we set up controls and who as person to do what and how we manage that…
But after that I believe we need to validate that the software does what we say in our SOPs and demonstrates sufficient control.
I think I understand at a high level what needs to be done (write scripts that demonstrate teh requirements of teh SOPs that have performed manually, then see if the excepted results are obtained) , but the devil is always in the details.
Does any one have any pointers on doing that or links to information or examples of how do do that?
Also we need to show long term document storage si safe (Disaster recovery , Data won’t be lost/ corrupted or issues with media or readability long term). So far I just required that all PDFs (how we store the documents ) are in PDF/A format.
Given that is in the cloud under Google control, I am no sure how we do that either!
Thanks for any input,
-karen
PS I wanted to write these systems myself using Postgres and Xojo. but they don’t want me to do that.