We have to qualify each GxP relevant computer systems on every day basis within our organization as per our SOP. In this process, on everyday basis, we qualify numbers of dekstops/laptops/servers/switches across all sites at multiple locations. We execute scripts of 21 steps which involves operation of software/hardwares testing, utility testing and configuration testing. We capture all screen shots and then finally take approval of all approvers on these paper documents and then place the Qualification summary report alonwith these screen shots in our documentation cell.
Now, my query is, is there any scope of keeping these documents electronically only and not in the paper based form, because we are consuming thousands of pages everyday. I wanted to save papers as well as to reduce the burden of document management manually putting it in some cell or Almirah in the record room.
Does the agency requires only paper based validation documents? If NO, can we use some testing tools which captures screen shots of every action and make a video files (e.g. .avi). Will this be acceptable to FDA in case if they require it.
Do they require paper? No. Can you use test tools to capture screen shots / movies? Yes.
What happens, though, is that you bring 21 CFR Part 11 into play for electronic records (and if you require signatures on your attachments then also for electronic signatures). You will want to validate the tools for their intended use (capture screen shots, capture video files). You will also need to show that you properly save and protect the files (including backup at controlled / managed facilities). You’ll probably want to do some mechanism by which you can show the files were not altered once captured; e.g., a zip file with a checksum. One trick will be associating the screen shots / movies with the protocol / results / report.
Certainly quite achievable, just a few more hoops to jump through.
Definetly one can use the Screenshot and Video tools for capturing the data. from the FDA / Regulatory agency perspective adequacy and accuracy of data alongwith integrity is being evaluated. So if you are able to retrive the accurate data from your electronic system adequately and with integrity…it’s not a big deal to use. Basic rule if you are dealing in Regulated world handling data which is qualfying agency requirements, process as well support tools need to be validated / qualified (as appropriate).